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DLP recallZ-2738-2026 · Medtronic Perfusion Systems · initiated May 25, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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 received two complaints of loose foreign material confirmed as containing trace levels of blood.

FDA root cause category: Packaging

What the company is doing

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 6/4/2026 via courier. The notice explained the problem, potential risk, and requested the product be discarded in a clearly marked biohazard bag or container and discarded. Consignees were directed to complete the enclosed Customer Confirmation Form and email to [email protected] and contact Medtronic Customer Service at 1-800-854-3570, Option 1 then Option 4, and reference this communication to initiate to arrange for credit or replacement product. Consignees were requested to share within their organization and If the product was forwarded to another facility, to notify those to whom the affected product was transferred.

Recall details

Recall number
Z-2738-2026
Status
Open, Classified
Initiated by the company
May 25, 2026
Posted by the FDA
Jul 15, 2026
Recalling firm
Medtronic Perfusion Systems
Product code
DWF
FDA submissions
K024069, K180456
Distribution
Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.

Product description

Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula

Code information (models, lots, serial numbers)

MATNR A7630009466801/UDI/DI 20763000946689, Lot Numbers: 0231650870, C232227220

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

23 devices cleared under K024069, K180456 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99199).

Sources and updates

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