Recalls

Particulate matter in the delivery system of Medtronic’s newly FDA approved CoreValve Evolut R system present enough risk to warrant and FDA Class 1 Recall

GE Healthcare is pointing to in-field modifications for the introduction of a serious condition to many of its installed MRI systems around the world

Cardica, Inc. is to pull the remainder of the latest iteration of its MicroCutter XCHANGE 30® from sale, drawing a line under the device until a next generation version is ready.

When a device is relied on to provide distraction, it’s obviously alarming when it has the potential to reverse direction. The consequences are significant enough to warrant the FDA classifying Depuy Synthes’ recall as Class I.

Cook Medical has initiated a recall of 696 of its CloverSnare™ 4-Loop Vascular Retrieval Snare devices because of a potential for device failure with serious consequences.

The Medtronic Duet External Drainage and Monitoring System is now the subject of a Class I recall because of concerns that tubing may separate, with serious consequences for patients.

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.

No doubt timed to coincide with the FDA’s Class I recall notice, HeartWare International, Inc. has itself issued a clinician and patient reminder concerning last December’s Urgent Medical Device Correction relating to its Ventricular Assist System.

Covidien plc has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

Teleflex Medical has announced a worldwide voluntary recall of its ISIS™ HVT™ Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet).

Codman Neuro has announced changes to the instructions for use for its TRUFILL® n-BCA Liquid Embolic System. It seems incorrectly mixed product can result in embolization or reflux, which has lead the U.S. FDA to label the company’s medical device correction notice as a Class I recall.

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.

Intuitive Surgical has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace daVinci robotic surgery device components as necessary to avoid a friction-induced stalling problem.

The US FDA has issued its highest category of of recall (Class I) for a variety of Medtronic Guidewires, due to the potential for their PTFE coating to part company with the core.

It’s ironic that an embolus filter should find itself the subject of a recall for presenting a risk of embolus. It’s also reassuring that the company, Edwards Lifesciences, should take such a prudent step without having identified a single occurrence of the risk for which its device is being recalled.

The FDA has issued a Class I recall notice on certain product codes and lot numbers of Bard’s LifeStent Solo Vascular Stent, manufactured between November 2011 and June 2012. The reason for the recall is a potential failure to deploy the stent, which would have potentially serious adverse health consequences