Medtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula Model 94665 due to potential sterile barrier breach. The product is used in cardiopulmonary bypass procedures worldwide.
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 of a sterile medical device with a potential sterile barrier breach—a defect that poses a direct risk of harm (infection, contamination) in a high-risk surgical application (cardiopulmonary bypass). No reported illnesses or injuries are stated in the source, but the nature of the hazard (sterile barrier failure) and product use context (invasive cardiac procedure) warrant a High severity score.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665, a cardiopulmonary bypass vascular catheter. The recall affects 840 units distributed worldwide, including the United States and numerous other countries.
Certain lots of the product have the potential for a sterile barrier breach. The affected lot numbers are 0231823435, 0231961203, and 0231823478 (exact GTIN and lot combinations are documented by the manufacturer).
Patients and healthcare providers who have this product should contact Medtronic Perfusion Systems for instructions on product replacement or return. Healthcare facilities should review their inventory to identify affected units and take appropriate action to ensure patient safety.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
- contamination
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 (6)
- GTIN 00643169454705
- Lot Numbers: 0231823435
- 0231961203
- GTIN 20643169454709
- 0231823478
- 0231961203.
Distribution
Distributed nationwide across the United States.