Medtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
Medtronic is recalling certain lots of its DLP Retrograde Cannula (Model 94725), a cardiopulmonary bypass catheter, because the sterile barrier may be breached, potentially allowing contamination. The cannulas were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall involving a sterile barrier defect on an invasive cardiac device used in high-risk surgical procedures where infection could lead to serious patient harm. Class II recalls with infection/contamination risk warrant a Severe score.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94725), a vascular catheter used in cardiopulmonary bypass procedures. Approximately 2,620 units are affected.
The recalled product has the potential for a sterile barrier breach. A compromised sterile barrier may allow bacterial or other contamination to enter the product, posing a risk of infection to patients who receive procedures using the affected cannulas.
The affected lot numbers include: 0231650787, 0231758255, 0231862812, C231966207, 0231937422, 0231650793, 0231758250, 0231758279, 0231758282, 0231823523, C231965721, C232428221, and C232430086, distributed worldwide including the United States, Canada, Australia, and numerous other countries.
Patients who received procedures with affected cannulas or healthcare facilities with affected inventory should contact Medtronic Perfusion Systems for instructions on how to proceed.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
- infection-risk
- 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 (17)
- GTIN 00643169454736
- Lot Numbers: 0231650787
- 0231758255
- 0231862812
- C231966207
- GTIN 00673978188713
- Lot Numbers: 0231937422
- GTIN 20643169454730
- 0231650793
- 0231758250
- 0231758279
- 0231758282
- 0231823523
- 0231937422
- C231965721
- C232428221
- C232430086.
Distribution
Distributed nationwide across the United States.