Troubled Medtronic (NYSE: MDT) subsidiary Physio-Control Inc. was hit with an FDA recall due to battery problems with one of the company’s defibrillators.
The U.S. Food and Drug Administration issued a Class I recall, the agency’s most serious type of recall, because Physio-Control’s LifePak 20 and 20e monitor/defibrillators can lose power due to a battery malfunction when they’re not plugged in to an electricity source, according to a notice from the FDA.
Physio-Control issued a “field correction” of the device last week, after discovering that it might lose battery power while in operation, but the FDA recall indicates this is a more-serious matter. Class I recalls are issued when there’s a “reasonable probability” that use of the devices in question could result in “serious adverse health consequences or death,” the FDA said.
About 43,000 of the devices in question were distributed between 2002 and 2007. Redmond, Washington-based Physio-Control began mailing notification letters to customers in May and will update the affected devices, according to the FDA.
In April, the FDA issued a Class I recall of Physio-Control’s LifePak 15 monitor/defibrillator for a defect that could also cause power loss.
In February, the FDA gave the company approval to resume selling its automated external defibrillators, which Physio-Control voluntarily stopped shipping in 2007 because of concerns about its quality-control procedures.
The problems with the FDA prevented Medtronic from moving forward with a planned spin-off of Physio-Control. Medtronic said in December that the spin-off was on hold until at least the end of fiscal 2010.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In February, CEO Bill Hawkins was noncommittal about when Medtronic would resume divesting the business. He said the company would wait because it needed time to restore relations with its customers.
