Medtronic Inc. subsidiary Physio-Control is causing its parent company headaches again, this time with a recall of its LifePak 15 monitor/defibrillator.
The Food and Drug Administration classified Medtronic’s decision to recall the device as a Class I recall, according to Medtronic (NYSE: MDT). That’s the most serious type of recall and one that concerns products that can cause “serious adverse health consequences or death,” according to the FDA.
However, Medtronic said there have been no “adverse patient events” related to the issue. The recall applies to versions of the LifePak 15 monitor/defibrillator that were manufactured before Dec. 16, 2009.
Physio-Control said the affected devices were manufactured with an internal component that could cause an electrical short that leads to the device turning off or on by itself, or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy.
Defibrillators are computerized medical devices that check a patient’s heart rhythm and are capable of delivering an electrical shock to correct an irregular rhythm.
Physio-Control said it notified affected customers of the problem on March 4 and has begun servicing the devices for free. The company recommends that customers continue using the device, but test it following its operating instructions.
The latest blow to Physio-Control comes after the company received some good news in February. At the time, 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.
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.
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.
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.
With Physio-Control’s latest problems, that wait may have just gotten longer.
