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Terminated

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

FDA Recall Z-1489-04 · Posted 2004-09-29

Recalling FirmMedtronic Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2004-09-15
Date Terminated2005-11-03
Product Quantity753 units, 203 distributed in US to 24 customers.

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide throughout the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMedtronic Blood Systems, Inc. · 1989-05-31K845045VENOUS RETURN CATHETER SS-1Dlp, Inc. · 1985-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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