Z-2806-2026Class II
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an...
Medtronic Perfusion Systems / initiated 2026-06-24 / Open, Classified
Medtronic Perfusion Systems began a recall of EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 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-2806-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- 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
- 21,290 units
- Distribution
- Worldwide - US Nationwide distribution.
- Product codes and lots
- UDI-DI: 20763000135632, Lot Numbers: 0232446429 0232446444 0232486752 0232601515 0232601516 0232601522 0232601586 0232601591 0232601593 0232602180 0232798265 0232798353 0232849583 0232894981 0232895082 0232902694 0232902697 0232902698 0232902700 0232902803 0232902805 0232902846 0232985469 0233009922 0233108251 0233116991 0233127352 0233334923 0233334966 0233426694 0233426695 0233528727; UDI-DI: 00763000135638, Lot Numbers: 0232446444 0232798353 0232895082 0232902697 0232902803 0232902846 0232985469 0233127352 0233334923
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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