Medtronic DLP VAD Venous Cannula for Ventricular Assist… recallZ-1489-04 · Medtronic Inc · initiated Sep 15, 2004
Terminated All recalls posted in September 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1489-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 15, 2004
- Posted by the FDA
- Sep 29, 2004
- Recalling firm
- Medtronic Inc
- Quantity
- 753 units, 203 distributed in US to 24 customers.
- Product code
- DWF
- FDA submissions
- K845045, K891687
- Distribution
- Nationwide throughout the United States and worldwide.
Product description
Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
Code information (models, lots, serial numbers)
Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
Other devices under the same FDA submission
52 devices cleared under K845045, K891687 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA CB7X82R4Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J98R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB7J97R8Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
- NA CB10W63R1Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 66128Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 66132Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- VC2™ 93448CMedtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall1 report
- NA CB4Z27RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB5S68R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6M85R7Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB7D52RMedtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
- NA CB6Z18R3Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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