—#206797

Product

Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003

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: a) Model Number 30004, GTIN 00613994646156, Lot Numbers: 2023041305; a) Model Number 30004, GTIN 00673978179841, Lot Numbers: 2023041300; a) Model Number 30004, GTIN 20613994646150, Lot Numbers: 2023041300, 2023041305, 202306C194; b) Model Number 30003, GTIN 20613994646174, Lot Numbers: 2023041298, 202306C221

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 #206797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.