Recalls / —

—#35015

Product

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

FDA product code

DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K845045, K891687

Affected lot / code info

Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.

Why it was recalled

Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Medtronic Inc

Address

710 Medtronic Pkwy, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern

Nationwide throughout the United States and worldwide.

Timeline

Recall initiated

2004-09-15

Posted by FDA

2004-09-29

Terminated

2005-11-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.