Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-

FDA device recall Z-1109-2007 · posted 2007-07-27 · Terminated

Recall details

Recalling firm

Thoratec Corp

Reason for recall

Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths

Action taken

The firm has issued an Urgent Medical Device Correction notice dated March 30, 2007, to all VAD customers alerting them to the hazard. The letter instructs them that a Thoratec representative will be contacting them to make arrangements to apply a warning label to the affected devices. The letter also informs them to dispose of any expired original design caged tip atrial cannula and to 1) not use the black collet and nut with any current design VAD, 2) make sure that all current patients using PVADs are using the appropriate collet nut, and 3) provide a copy of the product safety bulletin to all outlying hospitals and/or physicians that may be following patients implanted with PVADs and provide contact information with the acknowledgement form.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

2,484 units

Distribution

Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.

Date initiated

2007-03-30

Date posted

2007-07-27

Date terminated

2008-04-24

Location

Pleasanton, CA