Recalls / —

—#211789

Product

DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

FDA product code

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

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K024069

Affected lot / code info

Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097

Why it was recalled

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

Root cause (FDA determination)

Packaging

Action the firm took

An URGENT: MEDICAL DEVICE RECALL notification letter dated 12/12/24 was sent to customers. Patient Recommendations: Patients previously supported with an impacted device face no additional risk from the issue described in this communication and should continue to be monitored per your practice s normal follow-up procedures. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed product. " Immediately identify and quarantine all unused, listed product in your inventory. " Return unused, listed product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570, Option 1 then Option 4, and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as necessary. " Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession. " Please share this notification with others in your organization as appropriate. If product listed above has been forwarded to another facility, please notify the facility of this . " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact your Medtronic Field Representative.

Recalling firm

Firm

Medtronic Perfusion Systems

Address

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

Distribution

Distribution pattern

Worldwide - US Nationwide distribution.

Timeline

Recall initiated

2024-12-12

Posted by FDA

2025-01-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #211789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.