DLP recallZ-1316-2024 · Medtronic Perfusion Systems · initiated Feb 7, 2024
Open, Classified
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 Perfusion Systems 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
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.
FDA root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-1316-2024
- Status
- Open, Classified
- Initiated by the company
- Feb 7, 2024
- Posted by the FDA
- Mar 19, 2024
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 4343 units
- Product code
- DWF
- FDA submissions
- K810820
- Distribution
- US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
Product description
Medtronic DLP Vessel Cannula, Model Number REF 30000
Code information (models, lots, serial numbers)
UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DLP® 30000Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall4 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K810820 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DLP® 31001Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall3 reports
- DLP® 30004Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 30003Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 31002Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 report
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 16, 2026. Text above is shown as published by the FDA.
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