FDA Device

Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108

Hazard

The product is mislabeled, in that the LVAD Pneumatic Lead 5' is identified with a BLUE Collar (instead of Red) in order to distinguish RVAD.

What You Should Do

Remedy

On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Products

Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
Brand
Thoratec Corp
UPC
Lot Number: 17482

Units Affected

45 units