Medtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
Medtronic Perfusion Systems is recalling certain lots of the DLP Retrograde Cannula (Model 94215T) due to a potential sterile barrier breach. The affected product is a cardiopulmonary bypass vascular catheter distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class II device recall where the hazard involves sterile barrier compromise, which creates risk of infection in a high-risk surgical context. Although no reported hospitalizations or illnesses are documented in the source text, Class II classification combined with the inherent risk of sterile barrier breach in a cardiopulmonary bypass device meets the Severe threshold.
Plain-English summary
Medtronic Perfusion Systems is recalling certain lots of the Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR (Model 94215T), a cardiopulmonary bypass vascular catheter. The recalled lots are identified by the following lot numbers: 0231881762, 0231881786, 0231931962, 0231962106, and C233032040.
The product has the potential for a sterile barrier breach. This device is used in cardiopulmonary bypass procedures and has been distributed worldwide, including throughout the United States and to numerous countries in Europe, Asia, Africa, and the Americas.
Patients who have received this device or healthcare providers who have this product on hand should contact Medtronic Perfusion Systems for further guidance. Affected individuals should consult their healthcare provider if they have any concerns about their treatment.
The recalled product
- Product
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 600
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 20643169454556
- Lot Numbers: 0231881762
- 0231881786
- 0231931962
- 0231962106
- C233032040.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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