Medtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
Medtronic is recalling certain lots of GUNDRY Retrograde Cannula (Model 94115T) cardiopulmonary bypass vascular catheters due to potential sterile barrier breach. The affected product has been distributed 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 for a cardiopulmonary bypass vascular catheter with potential sterile barrier breach—a significant risk-of-harm defect in a critical-use medical device. The source text does not report any illnesses or injuries, so the score remains at the maximum for theoretical risk: 3 (High).
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94115T), a cardiopulmonary bypass vascular catheter. The recall affects 6,572 units distributed worldwide, including in the United States and 39 other countries.
The recalled lots have the potential for a sterile barrier breach. The affected lot numbers are: 0231545565, C231958117 (GTIN 00643169454521); and 0231545557, 0231545560, 0231545565, 0231545567, 0231545569, 0231592142, 0231592228, 0231592241, 0231665664, 0231665707, 0231665708, 0231665711, 0231665712, 0231665713, 0231665714, 0231665715, 0231665716, 0231667178, 0231823613, 0231823689, 0231823700, 0231846134, 0231862819, 0231912810, C231958117, C231958118, C231958119, C231958120, C232287623 (GTIN 20643169454525).
Patients and healthcare providers who have received or used this product should contact Medtronic for instructions on return or replacement. Healthcare facilities should review their inventory and quarantine affected units immediately.
The recalled product
- Product
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- sterile-barrier-breach
- contamination-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 (20)
- GTIN 00643169454521
- Lot Numbers: 0231545565
- C231958117
- GTIN 20643169454525
- Lot Numbers: 0231545557
- 0231545560
- 0231545565
- 0231545567
- 0231545569
- 0231592142
- 0231592228
- 0231592241
- 0231665664
- 0231665707
- 0231665708
- 0231665711
- 0231665712
- 0231665713
- 0231665714
- 0231665715
Distribution
Distributed nationwide across the United States.