tag:www.gov.uk,2005:/drug-device-alerts 2025-03-19T13:41:31+00:00 HM Government tag:www.gov.uk,2005:/drug-device-alerts/suzhou-surgicare-disposable-hysteroscopy-sheath-recall-due-to-withdrawn-ce-certificate-dsi-slash-2025-slash-001 2025-03-19T13:41:31+00:00

The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine, and stop supply of any identified p�

tag:www.gov.uk,2005:/drug-device-alerts/philips-respironics-bipap-a-series-ventilators-alarm-malfunction-and-risk-of-therapy-interruptions-in-ventilators-not-intended-for-life-support-dsi-slash-2024-slash-006 2024-10-02T12:03:28+01:00

Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los�

tag:www.gov.uk,2005:/drug-device-alerts/cpt-hip-system-femoral-stem-12-slash-14-neck-taper-increased-risk-of-postoperative-periprosthetic-femoral-fracture-dsi-slash-2024-slash-007 2024-09-04T11:02:03+01:00

Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a sim�

tag:www.gov.uk,2005:/drug-device-alerts/symbios-origin-r-posterior-stabilised-patient-matched-total-knee-replacement-device-risk-of-early-revision-dsi-slash-2024-slash-005 2024-04-23T11:31:22+01:00

The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.

tag:www.gov.uk,2005:/drug-device-alerts/0-dot-9-percent-sodium-chloride-solutions-for-irrigation-inhalation-and-eyewash-recall-from-manufacturer-legency-remedies-dsi-slash-2024-slash-004 2024-04-04T14:02:30+01:00

Batches of Legency Remedies Pvt Ltd irrigation, inhalation and eye wash saline products manufactured between April and November 2023 are being recalled due to potential microbiological contamination.

tag:www.gov.uk,2005:/drug-device-alerts/counterfeits-and-unbranded-copies-of-lifevac-anti-choking-devices-may-fail-to-work-correctly-or-worsen-choking-incidents-if-used-dsi-slash-2024-slash-003 2024-03-25T11:00:08+00:00

Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK o�

tag:www.gov.uk,2005:/drug-device-alerts/magec-x-system-nuvasive-specialized-orthopedics-nso-uk-suspension-lifted-dsi-slash-2024-slash-002 2024-03-12T15:12:07+00:00

The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.

tag:www.gov.uk,2005:/drug-device-alerts/paclitaxel-coated-devices-pcd-used-in-the-treatment-of-peripheral-arterial-disease-update-to-previous-mhra-guidance-on-use-where-indicated-pcd-can-be-considered-as-a-treatment-option-for-both-critical-limb-ischaemia-cli-and-interm 2024-02-05T13:37:23+00:00

Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD).

tag:www.gov.uk,2005:/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-11 2023-11-24T11:03:47+00:00

Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.

tag:www.gov.uk,2005:/drug-device-alerts/sterifeed-colostrum-collection-device-and-risk-of-choking-due-to-infant-airway-occlusion-dsi-slash-2023-slash-010 2023-10-10T14:00:27+01:00

The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as the cap, if not removed, can easily get dislodged and become stuck in�

tag:www.gov.uk,2005:/drug-device-alerts/no-react-r-cardiovascular-bioprosthesis-implantables-discontinuation-of-ce-marking-and-manufacture-remaining-stock-may-continue-to-be-used-and-any-adverse-incidents-reported-nationally-dsi-slash-2023-slash-009 2023-09-04T14:00:33+01:00

The MHRA emphasises the importance of national reporting of any suspected adverse incidents associated with the product following CE certification withdrawal and cease of manufacturing.

tag:www.gov.uk,2005:/drug-device-alerts/ethypharm-aurum-pre-filled-syringes-are-incompatible-with-some-manufactured-needle-free-connectors-risk-of-delay-in-administering-potentially-lifesaving-medication-dsi-slash-2023-slash-008 2023-08-22T11:51:33+01:00

Attaching an incompatible needle-free connector (NFC) to an Ethypharm Aurum pre-filled syringe can block the syringe and prevent delivery of potentially lifesaving medicine. Only compatible NFCs should be used with pre-fille�

tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-update-of-previous-quarantine-advice-after-identification-of-likely-cause-dsi-slash-2023-slash-007 2023-08-03T13:57:50+01:00

The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses.

tag:www.gov.uk,2005:/drug-device-alerts/nuvasive-specialized-orthopedics-nso-precice-titanium-systems-uk-suspension-lifted-dsi-2023-slash-006 2023-04-12T09:59:41+01:00

The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte �

tag:www.gov.uk,2005:/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-update-to-dsi-slash-2023-slash-002-dsi-slash-2023-slash-005 2023-04-04T11:02:14+01:00

The MHRA is providing an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life).

tag:www.gov.uk,2005:/drug-device-alerts/bd-bodyguard-microsets-and-residual-ethylene-oxide-devices-may-continue-to-be-used-to-treat-paediatric-patients-5kg-and-above-dsi-slash-2023-slash-004 2023-02-20T15:55:47+00:00

As a precautionary measure, following an MHRA assessment of currently available data on EO levels, alternative devices to the BD BodyGuard Microsets should be sought in users of 5kg bodyweight and below.

tag:www.gov.uk,2005:/drug-device-alerts/nexgen-knee-replacement-affected-patients-should-be-offered-additional-follow-up 2023-02-15T12:43:56+00:00

The National Joint Registry (NJR) has identified that both the NexGen® Stemmed Option Tibial Components, when paired with either the Legacy® Posterior Stabilized (LPS) Flex Option Femoral or the LPS Flex Gender Solutions Fem�

tag:www.gov.uk,2005:/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-dsi-slash-2023-slash-002 2023-01-31T15:31:47+00:00

Carnamedica has identified issues with third-party suppliers, which could result in microbiological contamination, particulate matter within the solution, and leakage of fluid.

tag:www.gov.uk,2005:/drug-device-alerts/eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-stop-using-immediately-and-quarantine-all-preloaded-eyecee-one-lenses-dsi-slash-2023-slash-001 2023-01-26T09:10:36+00:00

The MHRA is aware of reports of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs).

tag:www.gov.uk,2005:/drug-device-alerts/haemodialysis-and-haemofiltration-machines-actions-to-take-following-pressure-related-alarms-to-avoid-unintentional-alteration-of-alarm-limits-dsi-slash-2022-slash-004 2022-09-21T16:24:51+01:00

Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. If the cause of the alarm is not addressed, the machine may not re�

tag:www.gov.uk,2005:/drug-device-alerts/paclitaxel-drug-coated-balloons-dcbs-or-drug-eluting-stents-dess-updated-position-on-use-in-patients-with-critical-limb-ischaemia-and-intermittent-claudication-dsi-slash-2022-slash-003 2022-04-05T17:08:23+01:00

The MHRA’s recommendations for using paclitaxel-coated devices in patients with intermittent claudication and critical limb ischaemia.

tag:www.gov.uk,2005:/drug-device-alerts/surdial-x-haemodialysis-machine-potential-for-devices-to-remove-excess-fluid-outside-of-machine-specification-dsi-slash-2022-slash-002 2022-02-17T13:57:20+00:00

The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who are unable to tolerate excess fluid removal.

tag:www.gov.uk,2005:/drug-device-alerts/stop-using-vaginal-speculums-with-smoke-tube-and-gynaecological-hysteroscopy-sheaths-from-gemini-surgical-uk-all-lots-and-batches-dsi-slash-2022-slash-001 2022-02-17T13:26:23+00:00

The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied CE mark. This means that these devices have been sold wit�

tag:www.gov.uk,2005:/drug-device-alerts/rheovalves-disposable-needle-free-valves-stop-using-specific-lots-due-to-risk-of-breakage-in-patient-dsi-slash-2021-slash-010 2021-12-20T16:02:36+00:00

Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk of the device breaking in use.

tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-december-2021 2021-12-03T15:20:25+00:00

Following our latest review of medical device alerts, we have archived the ones listed below.

tag:www.gov.uk,2005:/drug-device-alerts/handpieces-used-in-the-phacoemulsification-technique-of-cataract-removal-need-for-careful-cleaning-dsi-slash-2021-slash-009 2021-11-24T09:51:01+00:00

Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination of medical devices.

tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-november-2021 2021-11-09T11:56:24+00:00

Following our latest review of medical device alerts, we have archived the ones listed below.

tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-october-2021 2021-10-07T10:18:25+01:00

Following our latest review of medical device alerts, we have archived the ones listed below.

tag:www.gov.uk,2005:/drug-device-alerts/medical-device-alerts-archived-in-september-2021 2021-09-02T12:38:02+01:00

Following our latest review of medical device alerts, we have archived the ones listed below.

tag:www.gov.uk,2005:/drug-device-alerts/medical-devices-sterilised-by-steril-milano-potential-for-incomplete-sterilisation-dsi-slash-2021-slash-008 2021-06-29T16:44:44+01:00

Fraudulent activity by this third-party sterilisation provider has been identified. Multiple medical device manufacturers are affected. Manufacturers are advising customers of actions required to mitigate risks.

tag:www.gov.uk,2005:/drug-device-alerts/recall-of-bd-venflon-pro-safety-iv-cannula 2021-05-20T11:14:17+01:00

Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.

tag:www.gov.uk,2005:/drug-device-alerts/targeted-communication-ce-mark-suspended-for-all-magec-systems-manufactured-by-nuvasive-specialized-orthopedics-inc 2021-05-10T15:51:13+01:00

Recommendations for clinicians including not implanting these devices

tag:www.gov.uk,2005:/drug-device-alerts/total-parenteral-tpn-and-enteral-nutrition-bags-manufactured-by-diffuplast-sterilisation-issue 2021-04-20T16:55:22+01:00

Diffuplast has identified a potential issue with their third-party sterilisation provider. The risk to patients is very low and therefore patients should continue to use their products as normal.

tag:www.gov.uk,2005:/drug-device-alerts/dexcom-g6-sensor-untested-barrier-methods-to-reduce-skin-reactions 2021-04-06T15:43:48+01:00

Users of this continuous glucose monitoring system may experience adverse skin reactions to the sensor.

tag:www.gov.uk,2005:/drug-device-alerts/medoject-sterile-hypodermic-and-blunt-fill-needles-manufactured-by-chirana-t-injecta-discontinue-use 2021-03-29T15:07:47+01:00

There is the potential for a black residue to be present on all Medoject hypodermic and blunt fill needles

tag:www.gov.uk,2005:/drug-device-alerts/targeted-letter-implantable-orthopaedic-devices-manufactured-by-implants-international-ltd-trading-as-xtremity-solutions-ltd 2021-02-26T15:30:24+00:00

Unknown risks following distribution of product after CE certificate withdrawal

tag:www.gov.uk,2005:/drug-device-alerts/medical-devices-safety-bulletin-mdsb-2020-02 2020-11-05T14:00:40+00:00

Regular safety information for healthcare professionals

tag:www.gov.uk,2005:/drug-device-alerts/medical-devices-safety-bulletin-mdsb-2020-01 2020-10-19T11:02:29+01:00

This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices. It is aimed at all parts of the hea�

tag:www.gov.uk,2005:/drug-device-alerts/philips-sterilizable-defibrillator-internal-paddles-specific-models-may-fail-to-deliver-therapy-if-pre-use-checks-are-not-followed 2020-07-23T13:00:50+01:00

Manufactured by Philips � defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-fixation-system-risk-of-implant-failure-prior-to-completion-of-bone-healing-mda-2020-020 2020-07-10T10:30:51+01:00

Manufactured by Synthes GmbH � cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.

tag:www.gov.uk,2005:/drug-device-alerts/abbott-trifecta-trifecta-gt-bioprosthetic-aortic-heart-valves-cases-of-structural-valve-deterioration-svd-mda-2020-019 2020-07-06T10:45:36+01:00

Manufactured by Abbott � cases of valvular insufficiency and early revision.

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-xl-defibrillator-monitor-therapy-selector-switch-may-fail-mda-2020-018 2020-06-30T10:00:03+01:00

Manufactured by Philips � the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.

tag:www.gov.uk,2005:/drug-device-alerts/philips-heartstart-mrx-monitor-defibrillators-may-fail-to-deliver-therapy-without-alerting-the-user-to-a-fault-in-the-event-of-internal-damage-mda-2020-016 2020-06-17T14:01:13+01:00

The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.

tag:www.gov.uk,2005:/drug-device-alerts/results-from-laboratory-based-tests-for-covid-19-antibodies-using-capillary-blood-sample-collection-kits-may-not-be-reliable-mda-2020-015 2020-06-08T10:01:28+01:00

This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)

tag:www.gov.uk,2005:/drug-device-alerts/covid-19-all-haemofiltration-systems-including-machines-and-accessories-serious-risks-if-users-don-t-follow-manufacturer-instructions-for-set-up-mda-2020-013 2020-04-10T13:00:03+01:00

All manufacturers � there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.

tag:www.gov.uk,2005:/drug-device-alerts/anaesthetic-machines-off-label-use-during-the-covid-19-pandemic-mda-2020-012 2020-04-08T16:20:58+01:00

All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-implant-all-magec-systems-supply-suspended-to-the-uk-mda-2020-011 2020-04-01T15:15:14+01:00

Manufactured by NuVasive Specialized Orthopedics � supply of all MAGEC rods suspended to the UK market during a review by MHRA.

tag:www.gov.uk,2005:/drug-device-alerts/spinal-implant-magec-system-model-x-rods-risk-of-failure-in-use-mda-2020-010 2020-03-18T14:09:20+00:00

Manufactured by NuVasive Inc. � risk of end cap separation after implantation.

tag:www.gov.uk,2005:/drug-device-alerts/tympanic-thermometers-revision-of-the-calibration-frequency-of-cardinal-health-genius-2-and-genius-3-models 2020-02-27T14:00:37+00:00

Manufactured by Cardinal Health � calibration period revised to 25 weeks instead of yearly to ensure these thermometers remain within their accuracy range and reduce the risk of misdiagnosis or delay in treatment.

tag:www.gov.uk,2005:/drug-device-alerts/various-olympus-duodenoscope-models-do-not-use-if-elevator-wires-are-frayed-or-damaged-as-these-may-cause-lacerations-to-patients-and-users 2020-02-27T12:01:49+00:00

Manufactured by Olympus Medical Systems Corp � instructions for use now say to inspect for frayed elevator wires before and after use to improve the detection of damage.