Z-0491-03

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

Name: Z-0491-03 Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
Creator: Thoratec Corp
Published: 2002-12-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-12-16 / Terminated / root cause: labeling and UDI

FDA source

Thoratec Corp began a recall of Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108 on 2002-12-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0491-03
Status: Terminated
Initiated: 2002-12-16
Posted: 2003-01-30
Terminated: 2003-08-21
Recalling firm: Abbott Medical
Product: Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.
Quantity in commerce: 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; 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.
Product codes and lots: Lot Number: 17482

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)