Medtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach
Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.
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 3/5 (High).
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: The recall involves a potential sterility breach in a surgical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 420 units of the DLP Aortic Root Cannula with Flow-Guard (REF 11012). These devices are used in cardiopulmonary bypass surgery. The recall is being conducted because there is a potential for a sterility breach in three specific lots of the product.
The issue stems from a misaligned seal, which could compromise the sterility of the cannula. The affected lots are identified by the numbers 2023050066, 202307C101, and 202401C304, with UDI/DI 20613994495451. The products were distributed in the United States (New York, Ohio, Illinois, New Jersey, Michigan, Tennessee, and Wisconsin) as well as in Australia and Singapore.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Perfusion Systems for further instructions. Patients who have undergone surgery with these specific devices should consult their healthcare provider if they have concerns regarding potential infection risks.
The recalled product
- Product
- Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 420
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 (4)
- UDI/DI 20613994495451
- Lot Numbers: 2023050066
- 202307C101
- 202401C304
Distribution
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