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Updated advice from manufacturers on device management for systems known or suspected to be contaminated with Mycobacterium chimaera.
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A list of all medical device alerts that were archived in October 2016.
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Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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If patients are contacted directly by a manufacturer or other organisation to try using a different insulin therapy system they should first discuss this with their diabetes specialist to avoid risk of hyperglycaemia, hypogl…
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Manufactured by St Jude Medical – risk of unpredictable, rapid battery depletion leading to potential device failure and loss of therapy.
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Manufactured by Roche Diabetes Care - inadequately detailed handling instructions of the 'Key Lock' function of the pump may lead to unintentional operation, which could result in rapid and severe deterioration of he…
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A list of all medical device alerts that were archived in July 2016.
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Change to 2012 advice – current data supports the withdrawal of MDA/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under Action.
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A list of all medical device alerts that were archived in March 2016.
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CME has recommended the need for protection of these pumps when exposed to direct sunlight.
In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with…
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A list of all medical device alerts that were archived in December 2015.
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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Manufactured by Coloplast A/S – temporary suspension of the CE certificate due to particles found on some implantable devices made by their subcontractor Silimed lndustria de lmplantes Ltda - MDA/2015/036
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A list of all medical device alerts that were archived in September 2015.
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Suspension due to particles found on some devices (MDA/2015/034)
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A list of all medical device alerts that were archived in July 2015.
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(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)
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[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)
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(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…
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A list of all medical device alerts that were archived in May 2015.
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(Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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(St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)
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(All types, makes and models) Report cases in women who have breast implants or who have had them removed. (MDA/2014/027)
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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(Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear. (MDA/2014/018)
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(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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(Roche Diagnostics Ltd) Increased risk that the vibration alarm will not work as a result of a changed component. (MDA/2014/008)
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(Carestream Health) Risk of injury if joint between scissor arm and bracket fails. (MDA/2014/005)
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(All products) Could fail during use with a risk of injury to patient and user. (MDA/2014/004)
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(Sorin) Difference between predicted and actual pacemaker battery depletion characteristics. (MDA/2013/084)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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(Patterson Medical) May cause the user to fall. (MDA/2013/060)
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(Philips) Motorised geometry control system will reboot if users attempt simultaneous powered and manual movement of the C-arm. (MDA/2013/045R)
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(Philips) Table will reboot if users attempt a powered and manual movement at the same time. (MDA/2013/045)
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(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
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(Medtronic) May lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (MDA/2013/035)
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(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)
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(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
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(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)
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(Hospira) Due to pump faults. (MDA/2013/016)
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[Archived] (Finsbury Orthopaedics Ltd) Do not implant ADEPT® 12/14 modular head devices. (MDA/2013/010)
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(Hospira) Due to insulation abrasion. (MDA/2013/007)
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(Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)
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(Various manufacturers) Check labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy. (MDA/2012/075)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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[Archived] (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)
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(Q-Med AB - a Galderma division) problem with use of Macrolane VRF20 and Macrolane VRF30 for breast augmentation which can make diagnosis of breast cancer more difficult. (MDA/2012/022)