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EOPA recallZ-2807-2026 · Medtronic Perfusion Systems · initiated Jun 24, 2026

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

Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT: MEDICAL DEVICE RECALL notification letter dated June 2026 was sent to customers beginning 6/24/26. Customer Actions: Medtronic requests that you take the following actions: " Review your inventory for listed products using Attachment A. " 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 return for credit or replacement 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 the product listed above has been forwarded to another facility, please notify the facility of this Medtronic Urgent Medical Device Recall. " Please maintain a copy of this communication in your records. If you have any questions regarding this communication, please contact 1-800-854-3570, Option 1, then Option 4.

Recall details

Recall number
Z-2807-2026
Status
Open, Classified
Initiated by the company
Jun 24, 2026
Posted by the FDA
Jul 27, 2026
Recalling firm
Medtronic Perfusion Systems
Quantity
11,720 units
Product code
DWF
FDA submissions
K031037
Distribution
Worldwide - US Nationwide distribution.

Product description

EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522

Code information (models, lots, serial numbers)

UDI-DI: 00199150023288, Lot Numbers: 0233286436; UDI-DI: 20199150023282, Lot Numbers: 0232709428 0232744924 0232745061 0232745092 0232798556 0232862763 0232862778 0232862794 0232862798 0232903216 0232903291 0232903383 0232990983 0233286318 0233286414 0233286436 0233427120 0233528730 0233553623 0233556386 0233585113 0233585114 0232670802

Devices named in this recall

1 device 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 99320).

Sources and updates

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