FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic DLP Vessel Cannula, Model Number REF 30000
- Recall number
- Z-1316-2024
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic DLP Vessel Cannula, Model Number REF 30000
- Status
- Open, Classified
- Initiated
- 2024-02-07
- Posted
- 2024-03-19
- Terminated
- not on file
- Reason
- Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
- Root cause
- Packaging change control
- Action
- Medtronic Cardiac Surgery issued an Urgent: Medical Device Recall to its consignees on 02/07/2024 via UPS. The notice explained the issue, potential risk, and requested consignees identify and quarantine affected product, and arrange to return the affected product by contacting customer service at 1-800-854-3570, option 1, then Option 4. The notification should be shared with others in your organization as appropriate. If product was forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.
- Quantity
- 4343 units
- Distribution
- US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
- Lot, serial or model codes
- UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889
- 510(k) numbers
- ["K810820"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- 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