Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalog
FDA device recall Z-0015-2007 · posted 2006-10-04 · Terminated
Recall details
- Recalling firm
- Thoratec Corp
- Reason for recall
- During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
- Action taken
- On 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 11 units
- Distribution
- Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.
- Date initiated
- 2004-01-26
- Date posted
- 2006-10-04
- Date terminated
- 2007-11-27
- Location
- Pleasanton, CA
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