EOPA 3D recallZ-2810-2026 · Medtronic Perfusion Systems · initiated Jun 24, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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-2810-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2026
- Posted by the FDA
- Jul 27, 2026
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 3,621 units
- Product code
- DWF
- FDA submissions
- K260195
- Distribution
- Worldwide - US Nationwide distribution.
Product description
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Code information (models, lots, serial numbers)
UDI-DI: 20763000135700, Lot Numbers: 0232602300 0232602383 0232612916 0232680078 0232708967 0232709001 0232910880 0232910881 0232910882 0233077983 0233245850 0233245860 0233245980; UDI-DI: 00763000135706, Lot Numbers: 0232612916 0232709001
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EOPA 3D® 78222Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall6 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99320).
- Z-2806-2026 · Open, ClassifiedEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- Z-2807-2026 · Open, ClassifiedEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
- Z-2808-2026 · Open, ClassifiedEOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
- Z-2809-2026 · Open, ClassifiedEOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
- Z-2811-2026 · Open, ClassifiedEOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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