Recalls / —

—#206794

Product

Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001

FDA product code

DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K810820

Affected lot / code info

GTIN 00613994575319, Lot Numbers: 2023041320, 2023041323; GTIN 00673978180465, Lot Numbers: 2023041316, 2023041323; GTIN 20613994575313, Lot Numbers: 2023041316, 2023041318, 2023041320, 2023041323, 202305C146, 202305C154

Why it was recalled

Potential for unsealed sterile packing.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.

Recalling firm

Firm

Medtronic Perfusion Systems

Address

7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern

Worldwide distribution.

Timeline

Recall initiated

2024-03-19

Posted by FDA

2024-05-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #206794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.