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Terminated

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

FDA Recall Z-0491-03 · Posted 2003-01-30

Recalling FirmThoratec Corp
Recall StatusTerminated
Product CodeDSQ
Date Initiated2002-12-16
Date Terminated2003-08-21
Product Quantity45 units

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.

Firm Action

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

Root Cause

Other

Distribution Pattern

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; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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