FDA Class 1 Recall for Datascope/MAQUET’s Intra-Aortic Balloon Pump

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.

FDA Issues Class I Recall and HeartWare Issues Reminder About Driveline Connector Device Correction

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.

Delamination Risk Provokes Covidien Recall of PTFE Coated Vascular Products

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.

IFU Changes Mean Codman Neuro’s TRUFILL® n-BCA Liquid Embolic System Gets Class I Recall Status

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.

Class II Recall for Stalling Surgical Robot

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.

Edwards Lifesciences’ Embolus Filter Recall Reaches US

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.