The FDA slapped Thoratec ($THOR) with a Class 1 recall status--the most serious--for the company's HeartMate II pump, after the company issued new instructions to clinicians in order to prevent them from improperly implanting the device.
An FDA spokeswoman confirmed to Reuters that it designed the recall as Class 1, because patients could suffer serious problems or die if clinicians didn't follow the new implant instructions. As the news agency reports, Thoratec's shares plunged 4.4% once the recall was publicized.
Regulators posted the action Wednesday on their news site. Thoratec saw fit to issue a statement noting that it has already informed clinicians about the new instructions in an initial voluntary notice sent out Feb. 23, after receiving 29 reports that the device had a faulty component--a part known as a "bend relief," which as Reuters explains stops the outflow graft from the device from blocking blood flow by kinking. Interestingly, the company also points out that it announced the voluntary medical device correction notification March 19, and also that the FDA already posted last month.
Thoratec didn't expect any device returns, according to MassDevice's coverage of the recall, and the company also noted that it won't face any material impact.
Five of the 29 patients needed additional surgery. One patient died, Reuters notes, but the company told the publication that it wasn't sure if the death was connected to the bend relief.
- here's the Reuters story
- check out MassDevice's take