Z-1109-2007

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

Name: Z-1109-2007 Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number...
Creator: Thoratec Corp
Published: 2007-03-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-03-30 / Terminated / root cause: design

FDA source

Thoratec Corp began a recall of Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000 on 2007-03-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1109-2007
Status: Terminated
Initiated: 2007-03-30
Posted: 2007-07-27
Terminated: 2008-04-24
Recalling firm: Abbott Medical
Product: Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000.
Product code: DSQ Ventricular (Assist) Bypass
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
Root cause tag: design
FDA 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 in commerce: 2,484 units
Distribution: Class I Recall - Worldwide Distribution --- USA, Canada, Australia, Mexico, Singapore, Taiwan, Thailand, Austria, France, Germany, Israel, and Switzerland.
Product codes and lots: Catalog Number 14086-2550-000, bearing serial numbers 10745 or less

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)