Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular cathete
FDA device recall Z-2219-2026 · posted 2026-05-20 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Certain lots of product have the potential for a sterile barrier breach.
- Action taken
- Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 4/21/2026 via UPS. The notice explained the issue, potential risk. and requested that the affected product be returned by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate return for credit or replacement product. Consignees were directed to share this notification with others in your organization as appropriate. If the product listed above has been forwarded to another facility, please notify the facility. For questions regarding this communication, consignees were asked contact their Medtronic representative.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 3210 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia
- Date initiated
- 2026-04-21
- Date posted
- 2026-05-20
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET (K953945) | Dlp, Inc. | 1996-03-26 |
| VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 (K860149) | Dlp, Inc. | 1986-03-31 |