FDA Device Recall Z-0004-2007: Thoratec Corp

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0004-2007.

Recall Res Number

Z-0004-2007

Recalling Firm / Manufacturer

Thoratec Corp

FEI Number

2916596

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-08-25

Date Posted

2006-10-03

Date Terminated

2007-11-27

Product Code

DSQ

Event Number

36186

Product Quantity

114 devices (57 valves/2 per unit)

Product Description Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

Reason for Recall Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.

Action Details On 8/26/06, the firm issued letters to all its direct consignees, informing them of the affected product and providing 'IMPORTANT PRODUCT SAFETY BULLETIN'.

Distribution Pattern Worldwide distribution-USA including states of AL, CA, CT, FL, IL, IN, KY, LA, MA, ME, MI, MN, NC, NY, OH, PA, TN, TX, VA, WA, and WI., with 19 Foreign consignees Australia, Belgium, Canada*, Czech Republic, France, Germany, Ireland, Netherlands, Portugal, Switzerland, United Kingdom. (*Hospital Royal Victoria, Queen Elizabeth II/Capital Health, St. Paul's Hospital, Vancouver, Canada.)--

Code Information / Serial Numbers All Codes (Valve Disk Lot 20052904)

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-0004-2007

Recall Parameters & Description

Related Establishments / Registrations

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