FDA Medical Device Recalls (openFDA)
Medtronic Inc: Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
- Recall number
- Z-1489-04
- Recalling firm
- Medtronic Inc
- Product
- Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
- Status
- Terminated
- Initiated
- 2004-09-15
- Posted
- 2004-09-29
- Terminated
- 2005-11-03
- Reason
- Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
- 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
- 753 units, 203 distributed in US to 24 customers.
- Distribution
- Nationwide throughout the United States and worldwide.
- Lot, serial or model codes
- Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
- 510(k) numbers
- ["K845045","K891687"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3001504994
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28