Z-1489-04

Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036

Name: Z-1489-04 Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036
Creator: Medtronic Inc
Published: 2004-09-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-09-15 / Terminated

FDA source

Medtronic Inc began a recall of Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036 on 2004-09-15. The reason FDA records is "Spiral tip from DLP VAD cannula may be loose and potentially detach during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1489-04
Status: Terminated
Initiated: 2004-09-15
Posted: 2004-09-29
Terminated: 2005-11-03
Recalling firm: Medtronic, Inc.
Product: Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
FDA root cause: Other
Action: A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.
Quantity in commerce: 753 units, 203 distributed in US to 24 customers.
Distribution: Nationwide throughout the United States and worldwide.
Product codes and lots: Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.

Product code DWF

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)