FDA Device Recall Z-0015-2007: Thoratec Corp

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0015-2007.

Recall Res Number

Z-0015-2007

Recalling Firm / Manufacturer

Thoratec Corp

FEI Number

2916596

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-01-26

Date Posted

2006-10-04

Date Terminated

2007-11-27

Product Code

DSQ

Event Number

36138

Product Quantity

11 units

Product Description Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

Reason for Recall During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers Serial Numbers: 104, 106

Related Establishments / Registrations

THORATEC CORP Registration: 1218444 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
POLO CUSTOM PRODUCTS Registration: 1927395 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
Phillips-Medisize Costa Mesa LLC Registration: 2031044 View Registration
MINNETRONIX, INC. Registration: 2133810 View Registration
LOWELL,INC. Registration: 2134470 View Registration
MEDTRONIC, INC. Registration: 2182208 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
THORATEC CORP. Registration: 2916596 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
Thoratec Switzerland GMBH Registration: 3003306248 View Registration
BERLIN HEART GMBH Registration: 3004582654 View Registration
TERUMO CARDIOVASCULAR SYSTEMS THI PLANT Registration: 3005228872 View Registration
HeartWare, Inc. Registration: 3007042319 View Registration
BERLIN HEART, INC. Registration: 3008454189 View Registration
Thoratec Corporation Registration: 3008792657 View Registration
APPLIMED SA -CSSR Registration: 3010163695 View Registration
Greatbatch Medical S. de R.L. de C.V. Registration: 3011823740 View Registration
INVENTUS POWER Registration: 3012931014 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
VASCUTEK LTD. Registration: 9612515 View Registration

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Medical Device Recall: Z-0015-2007

Recall Parameters & Description

Related Establishments / Registrations

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