FDA DevicesClass II
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94...
Published: May 27, 2026Recall ID: Z-2222-2026Category: devicesCountry: US
Reason for Recall / Hazard
Certain lots of product have the potential for a sterile barrier breach.
Product Description & Identification
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Affected Products
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Additional Source Details
| Field | Value |
|---|---|
| City | Brooklyn Park |
| State | MN |
| Event id | 98786 |
| Address 1 | 7611 Northland Dr N |
| Code info | GTIN 20643169454815, Lot Numbers: 0231665658, C231786900. |
| Postal code | 55428-1088 |
| Report date | 20260527 |
| Product type | Devices |
| Product quantity | 260 units |
| Reason for recall | Certain lots of product have the potential for a sterile barrier breach. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260421 |
| Initial firm notification | Letter |
| Center classification date | 20260520 |
Overview
- Recalling FirmMedtronic Perfusion Systems
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.