Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- October 3, 2024
- Posted
- November 4, 2024
- Recall Number
- Z-0289-2025
- Quantity
- 420 units
- Firm Location
- Brooklyn Park, MN
Reason for Recall
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Distribution
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Lot / Code Info
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Root Cause
Process control
Action Taken
Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions.