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Recall Observatory FDA recall evidence

Device product

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

Z-2222-2026

April 21, 2026

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 98786
Status
Ongoing
Classification
Class II
Quantity
260 units
Official record key
device-enforcement:Z-2222-2026

Official wording

Reason: Certain lots of product have the potential for a sterile barrier breach.

Code information: GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier breach