Class I U.S. Food and Drug Administration

Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented recall: The catheters may not retain their shape

Recall published 1+ years ago

The catheters may not retain their shape.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The catheters may not retain their shape.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2482-2025
Published
September 10, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Perfusion Systems
Product type
Medical devices
Units affected
25261 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 20643169880935, 00643169880931, 00681490463423; Serial Numbers: 2023051189 2023060145 2023060432 2023061147 2023070491 2023070980 2023080157 2023080407 2023080408 2023080799 2023080800 2023081133 2023081134 2023081549 2023090236 2023090429 2023091017 2023091107 2023091108 2023100097 2023100098 2023100098 2023100643 2023100644 2023101026 2023101027 2023101367 2023101367 2023101368 2023110168 2023111663 2023111663 2023111663 2023111700 2023111701 2023111702 2023111703 2023111703 2023120176 2023120177 2023120178 2023120179 2023120719 2023120719 2023121046 2023121046 2023121256 2024010194 2024010195 2024010196 2024010197 2024010198 2024010199 2024010200 2024010201 2024010202 2024010202 2024011215 2024011216 2024011216 2024011217 2024011218 2024011219 2024011219 2024011220 2024011221 2024011221 2024030367 2024030367 2024030368 2024030368 2024030841 2024030842 202307C113 202308C250 202309C023 202311C008 202311C009 202312C206 202312C207 202312C208 202401C008 202402C088 202403C101 202403C102 202406C058
UPC codes
20643169880935, 00643169880931, 00681490463423

Products covered by this recall

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 20643169880935
  • 00643169880931
  • 00681490463423

Model or item number

On the rating label, the box or the instruction sheet.

  • 12115 — UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • 2023051189 2023060145 2023060432 20230611

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic Perfusion Systems — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medtronic Perfusion Systems — 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Perfusion Systems medical devices recalled?

The catheters may not retain their shape. The catheters may not retain their shape.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 20643169880935, 00643169880931, 00681490463423; model number 12115 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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