DLP recallZ-2480-2025 · 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-2480-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2025
- Posted by the FDA
- Sep 3, 2025
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 34549 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 12113 LV VENT 13FR, Model Number 12113
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UDI-DI: 20643169881338, 00673978176475, 00643169881334; Serial Numbers: 2023051188 2023060142 2023060144 2023060431 2023060762 2023061146 2023061146 2023070147 2023070147 2023070148 2023070148 2023070149 2023070149 2023070150 2023070150 2023070151 2023070490 2023070490 2023070979 2023080156 2023080797 2023080798 2023080798 2023081130 2023081131 2023081131 2023081132 2023081547 2023081548 2023081548 2023090234 2023090235 2023090427 2023090675 2023090979 2023090980 2023091104 2023091105 2023091105 2023091106 2023091106 2023100243 2023100243 2023100244 2023100641 2023100641 2023100642 2023101024 2023101025 2023101025 2023101365 2023101365 2023101366 2023110247 2023110308 2023110308 2023110312 2023110312 2023121249 2023121250 2023121250 2023121251 2023121251 2023121251 2023121252 2023121253 2023121254 2023121255 2024010470 2024010471 2024010472 2024010472 2024010473 2024010474 2024010474 2024010475 2024010475 2024010476 2024010476 2024010477 2024011016 2024011016 2024011214 2024031093 2024031094 2024031095 2024040067 2024040068 2024040068 2024040069 2024040070 2024040071 2024040245 2024040245 2024060793 202307C112 202308C248 202308C249 202309C022 202310C057 202310C058 202312C203 202402C086 202403C085 202403C086 202403C087 202406C057 202407C109
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
Product lines
Other devices under the same FDA submission
5 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® 12110Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall27 reports
- DLP® 12110Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall4 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-2481-2025 · Open, ClassifiedDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
- 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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