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

FDA device recall Z-0984-2025 · posted 2025-01-17 · Open, Classified

Recall details

Recalling firm

Medtronic Perfusion Systems

Reason for recall

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

Action taken

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.

Root cause

Packaging

Status

Open, Classified

Product code

DWF

Quantity affected

745 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-12-12

Date posted

2025-01-17

Location

Brooklyn Park, MN

Related 510(k) clearances