Alerts/Adverse Events

The U.S. FDA has deemed as a Class 1 recall the Datascope Corporation/MAQUET voluntary worldwide field correction, issued in March of certain of the company’s Intra-Aortic Balloon Pumps (IABPs). A potential mechanical failure means the system could shut down, with adverse patient consequences.

HeartWare International has issued another warning to its customers. This time its a voluntary Urgent Medical Device Correction related to all HeartWare® Ventricular Assist System batteries, product codes 1650 and 1650-DE.

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

Scottish vascular graft company Vascutek has announced the return to market of its Anaconda™ Bifurcate Body Stent Graft System. The system has been out of circulation since October 2013.

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.

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.

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.

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.

When Sweden’s device authority called for all PIPs to be removed last week their evidence was seized upon by UK … continue reading “UK Plastic Surgeons Jump On Swedish PIP Results”

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.

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.