DLP recallZ-2481-2025 · Medtronic Perfusion Systems · initiated Aug 6, 2025
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
The catheters may not retain their shape.
FDA root cause category: Process change control
What the company is doing
Medtronic Cardiac Surgery issued an Urgent Medical Device Recall notice to its consignees on 08/06/2025 via UPS 2nd day delivery. The notice explained the issue with the device, potential harms if used, and requested the following: Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " " " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months. If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available. For questions, please contact your Medtronic Field Representative.
Recall details
- Recall number
- Z-2481-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2025
- Posted by the FDA
- Sep 3, 2025
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 41200 units
- Product code
- DWF
- FDA submissions
- K834039
- Distribution
- Worldwide - US Nationwide distribution.
Product description
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UDI-DI: 20643169880676, 00643169880672, 00673978176468, 00763000946432, 20763000946436; Serial Numbers: 2023120708 2023120708 2023120709 2023120710 2023120711 2023120712 2023121041 2023121041 2023121042 2024011203 2024011203 2024011204 2024020135 2024020136 2024020137 2024020138 2024020138 2024020139 2024020140 2024020141 2024020141 2024020471 2024020472 2024020473 2024020474 2024020474 2024020474 2024020475 2024020475 2024020475 2024020806 2024020806 2024020806 2024030359 2024030360 2024030360 2024030361 2024030361 2024030361 2024030833 2024030833 2024030834 2024030834 2024030835 2024030835 2024031088 2024031088 2024050074 2024050075 2024050076 2024050403 2024050404 2024050761 2024050762 2024050763 2024050763 2024051075 2024051076 2024051265 2024060283 2024060284 2024060284 2024060285 2024060529 2024070340 2024070340 2024071120 2024071120 2024071121 2024071121 2024071122 2024071122 2024080225 2024080225 2024080465 2024080465 2024080690 2024081023 2024081024 2024090228 2024090229 2024090470 2024090470 2024090471 2024090767 2024090768 2024100621 2024100622 202312C204 202312C205 202401C295 202401C296 202403C144 202403C145 202403C146 202405C079 202405C080 202406C064 202406C065 202406C066 202409C128
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- DLP® 12110Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall27 reports
- DLP® 12110Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall4 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K834039 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® 12115Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall1 report
- DLP® 12001Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
- DLP® 12008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97295).
- Z-2480-2025 · Open, ClassifiedDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- Z-2482-2025 · Open, ClassifiedDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
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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