Z-2807-2026Class 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 77522 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-2807-2026
- 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 77522
- 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
- 11,720 units
- Distribution
- Worldwide - US Nationwide distribution.
- Product codes and lots
- 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
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.