Z-2809-2026Class II
EOPA Elongated One-Piece Arterial Cannula DIL TIP 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 DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 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-2809-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic Perfusion Systems
- Product
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
- 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
- 3,110 units
- Distribution
- Worldwide - US Nationwide distribution.
- Product codes and lots
- UDI-DI: 20199150023312, Lot Numbers: 0232657469 0232670800 0232744945 0232798410 0232862769 0232985251 0233116924 0233116931; UDI-DI: 00199150023318, Lot Numbers: 0232744945
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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