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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-2481-2025
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
41200 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
20643169880676, 00643169880672, 00673978176468, 00763000946432, 20763000946436

Products covered by this recall

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Check your product

The notice names 7 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.

  • 20643169880676
  • 00643169880672
  • 00673978176468
  • 00763000946432
  • 20763000946436

Model or item number

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

  • 12110 — UDI-DI

Serial number

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

  • 2023120708 2023120708 2023120709 20231207

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 20643169880676, 00643169880672, 00673978176468; model number 12110 — 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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