FDA warns Abbott on St. Jude Medical plant in California

The FDA yesterday issued another warning letter about a St. Jude Medical (NYSE:STJ) plant in California, now owned by Abbott (NYSE:ABT), that makes cardiac rhythm management products. It’s at least the 2nd time the federal safety watchdog has flagged the plant in Sylmar, which makes defibrillators and the Merlin home cardiac monitor. In 2012 the FDA slapped St. Jude with a warning letter over problems with the manufacture of its Durata defibrillator leads; that letter was closed out in July 2014. Abbott paid $25 million earlier this year to acquire St. Jude. The FDA said inspections at the plant in February turned up issues with the implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators made in Sylmar, stemming from battery problems that surfaced last year. St. Jude warned in October 2016 that there’s a risk that the lithium-based batteries used in its ICDs and CRT-Ds could form “lithium clusters” during high-voltage charging; the clusters could then cause a short circuit and deplete the battery within a day to a few weeks, rendering the device incapable of delivering therapy. There were 841 premature depletion incidents among 398,470 devices (roughly 0.21%), including 2 deaths “associated with the loss of defibrillation therapy as a result of premature battery depletion,” St. Jude said. The company failed to properly address the lithium bridging issue, sold some affected devices after the problem became known and u...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Wall Street Beat Abbott Cardiac Rhythm Management st-jude-medical Warning Letter Source Type: news