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

FDA device recall Z-0491-03 · posted 2003-01-30 · Terminated

Recall details

Recalling firm

Thoratec Corp

Reason for recall

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.

Action taken

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

Root cause

Other

Status

Terminated

Product code

DSQ

Quantity affected

45 units

Distribution

The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level;

Date initiated

2002-12-16

Date posted

2003-01-30

Date terminated

2003-08-21

Location

Pleasanton, CA