EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
FDA Recall Z-0985-2025 · Posted 2025-01-17
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Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeDWF
Date Initiated2024-12-12
Product Quantity930 units
Reason for Recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Firm Action
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 [email protected].
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
Distribution Pattern
Worldwide - US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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