FDA Medical Device Recalls (openFDA)
Thoratec Corp: Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
- Recall number
- Z-1109-2007
- Recalling firm
- Thoratec Corp
- Product
- Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
- Status
- Terminated
- Initiated
- 2007-03-30
- Posted
- 2007-07-27
- Terminated
- 2008-04-24
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 2,484 units
- Distribution
- Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
- Lot, serial or model codes
- Catalog Number 14086-2550-000, bearing serial numbers 10745 or less
- 510(k) numbers
- not on file
- PMA numbers
- ["P870072"]
- Product code
- DSQ
- Firm FEI
- 2916596
- Firm city
- Pleasanton
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28