—#210448

Product

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K790565
Affected lot / code info: UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304

Why it was recalled

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore

Timeline

Recall initiated: 2024-10-03
Posted by FDA: 2024-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210448. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.