FDA Enforcement
Class II
Ongoing
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Recall: Z-2221-2026
·
Reported May 27, 2026
Enforcement
- Recall Number
- Z-2221-2026
- Event ID
- 98786
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 27, 2026
- Initiation Date
- April 21, 2026
- Classification Date
- May 20, 2026
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States
Description
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Reason
Certain lots of product have the potential for a sterile barrier breach.
Code Info
GTIN 20643169454808, Lot Numbers: 0231859673.
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, 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.
Quantity
280 units