Bio-Medicus recallZ-2739-2026 · Medtronic Perfusion Systems · initiated May 25, 2026
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
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-2739-2026
- 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
- K153598
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
Product description
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Code information (models, lots, serial numbers)
MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Bio-Medicus™ 96530-115Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall0 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K153598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Bio-Medicus™ 96530-119Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass3 reports
- Bio-Medicus™ 96530-119Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
- Bio-Medicus™ 96530-121Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99199).
- Z-2738-2026 · Open, ClassifiedMedtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
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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