—#206241

Product

Medtronic DLP Vessel Cannula, Model Number REF 30000

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: UDI/DI 20613994646211, Lot Numbers: 2023020890, 202305C126, 2023020889

Why it was recalled

Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

Root cause (FDA determination)

Packaging change control

Action the firm took

Medtronic Cardiac Surgery issued an Urgent: Medical Device Recall to its consignees on 02/07/2024 via UPS. The notice explained the issue, potential risk, and requested consignees identify and quarantine affected product, and arrange to return the affected product by contacting customer service at 1-800-854-3570, option 1, then Option 4. The notification should be shared with others in your organization as appropriate. If product was forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall.

Recalling firm

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

Distribution

Distribution pattern: US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK

Timeline

Recall initiated: 2024-02-07
Posted by FDA: 2024-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206241. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.