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EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and… recallZ-0985-2025 · Medtronic Perfusion Systems · initiated Dec 12, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-0985-2025
Status
Open, Classified
Initiated by the company
Dec 12, 2024
Posted by the FDA
Jan 17, 2025
Recalling firm
Medtronic Perfusion Systems
Quantity
930 units
Product code
DWF
FDA submissions
K031037
Distribution
Worldwide - US Nationwide distribution.

Product description

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

Code information (models, lots, serial numbers)

Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

27 devices cleared under K031037 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96015).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page