Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the risk of potential inaccuracies caused by the Biopsy Depth Gauge Cycle View. When a user encounters this software issue, it may result in a prolonged procedure, the need for an additional surgical procedure, aborted procedure, tissue injury, including potential for life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.
FDA has identified this as a Class I recall, the most serious type of recall. There have been four complaints regarding this issue, but no reported injuries or death.
Medtronic is also still grappling with a Class I recall of its Puritan Bennett 980 Series ventilators, which the company initiated in November. A capacitor manufacturing assembly error prompted that recall. FDA recently noted that there have been six complaints and one death related to this problem.
In other recall news, Getinge/Datascope/Maquet is recalling the CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP), which are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.
FDA said these devices are being recalled due to complaints of fluid leaks, and that fluid entering the Cardiosave IABP may cause the pump to shut down unexpectedly or the inability to initiate therapy. The agency said there has been one death and 71 complaints reported about this problem.