Medtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94915), a cardiopulmonary bypass vascular catheter, due to potential sterile barrier breach.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a high-risk medical device (cardiopulmonary bypass catheter). A sterile barrier breach in such a device poses a significant risk of infection and serious harm, and the recall applies to a risk-of-harm product where injury has not yet been reported. Per the rubric, Class II recalls with significant risk merit a score of 3.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94915), a cardiopulmonary bypass vascular catheter. The recalled product has the potential for a sterile barrier breach.
The product has been distributed worldwide, including in the United States and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Vietnam. The affected lot number is 0231859673.
Healthcare providers and hospitals using this product should immediately contact Medtronic Perfusion Systems for specific guidance on the recalled units and obtain replacement devices. Any adverse events associated with this device should be reported to the FDA.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 20643169454808
- Lot Numbers: 0231859673.
Distribution
Distributed nationwide across the United States.
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