Z-2811-2026Class II
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula...
Medtronic Perfusion Systems / initiated 2026-06-24 / Open, Classified
Medtronic Perfusion Systems began a recall of EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2811-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
- Product code
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Reason for recall
- 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
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 1,424 units
- Distribution
- Worldwide - US Nationwide distribution.
- Product codes and lots
- UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2806-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2807-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2808-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2809-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2810-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2811-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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