All Articles in: Alerts/Adverse Events
Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.
With total joint implants, one tiny mistake can have significant consequences. In this case no patient injury has been reported, but labelling within the Mathys balanSys Knee system incorrectly matches tibial and femoral components, with the risk of subsequent instability and pain. The company has issued a field safety notice.
Device Alert for Upside Down Vena Cava FilterJanuary 3, 2014
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.
Internal Fault Prompts FDA Safety Communication on Philips’ HeartStart Auto DefibrillatorsDecember 5, 2013
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.
The FDA has issued an alert to health care providers and patients concerning its Amplatzer Atrial Septal Occluder (ASO). It seems that in very rare instances, tissue surrounding the device can erode, resulting in life-threatening emergencies that require immediate surgery.
A customer complaint investigation uncovered a potential problem with Edwards Lifesciences’ EMBOL-X Glide Protection System. It seems incidences of a bent tip may present a risk of breakage and subsequent embolization, so in the UK at least the company has issued a recall notice for certain batches.
MHRA Device Alert: CareFusion Infusion PumpsAugust 13, 2013
The UK’s regulatory overlord, the MHRA has issued a device alert pertaining to CareFusion’s Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Infusion pumps, product codes 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G
Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.
UK Plastic Surgeons Jump On Swedish PIP ResultsJune 11, 2013
When Sweden’s device authority called for all PIPs to be removed last week their evidence was seized upon by UK plastic surgeons in the form of their specialty body, the British Association for Aesthetic Plastic Surgeons (BAAPS) which is now …
Swedish Regulators Want All PIPs OutJune 5, 2013
According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.
Medical Device Alert: Unomedical Reinforced ET Tubes Potential To Delaminate And Restrict AirflowMay 30, 2013
The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.
The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.
Abbott’s MitraClip Suffers Untimely SetbackMarch 26, 2013
In short We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, but the advice of its circulatory devices panel was to approve the thing. We also don’t know whether a warning …
FDA Class I Recall For Lumenis VersaCut Tissue MorcellatorFebruary 26, 2013
Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing.
The FDA has issued a Class I recall, it’s highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose.
Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.
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