Medtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
Medtronic is recalling certain DLP One-Piece Pediatric Arterial Cannulas (Product Number 77010) due to complaints of loose foreign material containing trace levels of blood found in the devices.
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: FDA Class II medical device recall involving a risk-of-harm product (foreign material in a cardiopulmonary bypass cannula). No reported illnesses or injuries are stated in the source text, but the contamination poses a theoretical risk of harm during a critical surgical procedure.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010, a cardiopulmonary bypass vascular cannula. The recall was initiated after Medtronic received two complaints of loose foreign material that was confirmed to contain trace levels of blood.
The affected product was distributed nationwide in the United States across Maryland, California, Michigan, Washington, Pennsylvania, North Carolina, Florida, and Arkansas. The recall involves Lot Numbers 0231650870 and C232227220, identified by UDI/DI 20763000946689.
Patients and healthcare providers who have this device should contact Medtronic Perfusion Systems for further guidance. Healthcare facilities should review their inventory for the affected lot numbers and follow Medtronic's instructions for device handling and potential replacement.
The recalled product
- Product
- Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
- Manufacturer
- Medtronic Perfusion Systems
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 (3)
- MATNR A7630009466801/UDI/DI 20763000946689
- Lot Numbers: 0231650870
- C232227220
Distribution
Part of a larger recall action
This product is one of 2 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.
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