-
Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 5 others
- Issued:
-
Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze.
- Alert type:
- Medical device alert
- Medical specialism:
- General practice and 2 others
- Issued:
-
Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.
- Alert type:
- Medical device alert
- Issued:
-
Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 1 others
- Issued:
-
Endologix has stopped selling the Nellix EVAS device and is recalling unused stock.
- Alert type:
- Medical device alert
- Medical specialism:
- Radiology and 1 others
- Issued:
-
Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 3 others
- Issued:
-
Manufactured by GE Healthcare – Device may stop ventilation when in PSV Pro Mode and users may be unable to change gas and agent settings when using End-Tidal Control.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 8 others
- Issued:
-
Manufactured by Acutronic Medical Systems AG – Ventilator may switch off without user input, deliver incorrect ventilation or may fail to alarm.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 3 others
- Issued:
-
Philips M3538A lithium-ion batteries manufactured from 28 December 2017 to 20 March 2018 inclusive for the HeartStart MRx monitor/defibrillator may have an internal component failure.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump
- Alert type:
- Medical device alert
- Medical specialism:
- Care home staff and 3 others
- Issued:
-
Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients getting infections.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
Manufactured by Roche Diagnostics GmbH: affected CoaguChek test strips may give false high results for INR values above 4.5 when compared to laboratory results, this may lead to incorrect treatment decisions
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 21 others
- Issued:
-
Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028 – wire may breach packaging, compromising sterility of device.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 3 others
- Issued:
-
Manufactured by Philips – Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by Halyard Health – risk of some Flex Connectors in Closed Suction Kits becoming loose or disconnecting, which may interrupt patient ventilation.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 2 others
- Issued:
-
Roche (Ventana Medical Systems) has released an expansion of products affected by the reagent dispenser issues causing weak staining and the potential for false negative results and misdiagnosis.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 3 others
- Issued:
-
Manufactured by Newdeal SAS – Risk of infection from compromised packaging.
- Alert type:
- Medical device alert
- Medical specialism:
- Orthopaedics
- Issued:
-
UK update on Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA - ALCL)
- Alert type:
- Medical device alert
- Medical specialism:
- Cosmetic surgery and 4 others
- Issued:
-
Manufactured by Smith & Nephew – The device has a higher than expected risk of revision due to early component loosening.
- Alert type:
- Medical device alert
- Medical specialism:
- Orthopaedics
- Issued:
-
Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 2 others
- Issued:
-
Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by SAM Medical Products - An error in the manual sewing operations of devices manufactured from March 2017 to April 2018 may cause the seam holding the buckle to the belt to fail.
- Alert type:
- Medical device alert
- Issued:
-
Manufactured by Roche Diagnostics GmbH – Incorrect Limit of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, blood: intact erythrocytes, which may adversely impact patient treatment.
- Alert type:
- Medical device alert
- Issued:
-
Manufactured by BD (formerly Carefusion) – specific batches manufactured from July 2015 to Sept 2016 inclusive. Risk of leakage or disconnection of tubing caused by inadequately sealed connections.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 14 others
- Issued:
-
Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Draeger Medical Systems – misinterpretation of display may cause delay of treatment of neonatal jaundice.
- Alert type:
- Medical device alert
- Medical specialism:
- General practice and 2 others
- Issued:
-
Manufactured by Teleflex – various critical care devices manufactured from January to December 2017 inclusive have been placed on the market with incomplete packaging seals potentially leading to infection.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 7 others
- Issued:
-
Manufactured by Cook Medical – risk of electric shock or burn, and failure of the device to operate during IVF procedures because of non-compliant mains wiring.
- Alert type:
- Medical device alert
- Medical specialism:
- Obstetrics and gynaecology and 1 others
- Issued:
-
Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 17 others
- Issued:
-
Manufactured by Baxter Healthcare – undetected leaks may occur during use after repeated disinfection cycles causing hypovolemia
- Alert type:
- Medical device alert
- Issued:
-
Manufactured by Draeger – a software issue may prevent the activation of audible and visual invasive blood pressure measurement alarms, risking a delay to treatment
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 2 others
- Issued:
-
Manufactured by Roche Diagnostics GmbH – Under specific circumstances scheduled automatic QC measurements may no longer be performed and erroneous patient results may remain undetected.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
Manufactured by Becton Dickinson (BD) – Due to a material in the rubber stopper, affected blood collection tubes may not be compatible with assays using Anodic Stripping Voltammetry (ASV) methodology.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.
- Alert type:
- Medical device alert
- Medical specialism:
- Orthopaedics and 1 others
- Issued:
-
Manufactured by Caesarea Medical Electronics (CME) Ltd – a variation in battery size can cause problems with connections in the battery housing. (MDA/2018/010)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 16 others
- Issued:
-
Following our latest review of medical device alerts, we have archived the ones listed below.
- Alert type:
- Medical device alert
- Issued:
-
Manufactured by Intersurgical – Valves may be incorrectly oriented, resulting in overpressure of the bag (MDA/2018/009)
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by AFP Medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (MDA/2018/008).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Manufactured by Zimmer GmbH – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (MDA/2018/007).
- Alert type:
- Medical device alert
- Medical specialism:
- Infection prevention and 2 others
- Issued:
-
Manufactured by ICU Medical (formerly Hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (MDA/2018/006).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 13 others
- Issued:
-
Roche Tissue Diagnostics (Ventana Medical Systems) – Leaking and sticking reagent dispensers may cause weak staining on tissue samples, which may lead to false negatives and misdiagnosis.
- Alert type:
- Medical device alert
- Medical specialism:
- General surgery and 2 others
- Issued:
-
Manufactured by Teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 5 others
- Issued:
-
Manufactured by CooperSurgical: specific batches of products were manufactured with increased histamine levels in the gentamicin sulphate.
- Alert type:
- Medical device alert
- Medical specialism:
- Obstetrics and gynaecology
- Issued:
-
The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 18 others
- Issued:
-
Manufactured by Boston Scientific: specific models only – risk of syncope or pre-syncope due to periods of pacing inhibition from oversensing of the minute ventilation sensor signal (MDA/2018/001)
- Alert type:
- Medical device alert
- Medical specialism:
- Cardiology and 1 others
- Issued:
-
Risk of injury to the patient if the treadmill suddenly goes to top speed.
- Alert type:
- Medical device alert
- Medical specialism:
- Cardiology and 3 others
- Issued:
-
BD Alaris/Asena syringe pumps (specific product codes) – internal malfunction may cause PL3 alarm to sound and the infusion to stop (MDA/2017/036).
- Alert type:
- Medical device alert
- Medical specialism:
- Anaesthetics and 11 others
- Issued:
-
Manufactured by Maxter Catheters – patients could accidentally pull off the connector cap and choke on it. (MDA/2017/035)
- Alert type:
- Medical device alert
- Medical specialism:
- Paediatrics
- Issued:
-
Manufactured by Oxoid Ltd (ThermoFisher Scientific) – antibiotic (ceftazidime) concentration may decrease over time if test disc is stored between 2°C and 8°C: only specific lots are affected (MDA/2017/034)
- Alert type:
- Medical device alert
- Medical specialism:
- Infection prevention and 1 others
- Issued:
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