Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
FDA device recall Z-2739-2026 · posted 2026-07-15 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Action taken
- 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 RS.CFQFCA@medtronic.com 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.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- DWF
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
- Date initiated
- 2026-05-25
- Date posted
- 2026-07-15
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medtronic Bio-Medicus Adult Cannula Kit (K153598) | Medtronic, Inc. | 2016-01-15 |