CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
Eopa Elongated One-Piece Arterial Cannula Blunt recalled
Medtronic Perfusion Systems is recalling Eopa Elongated One-Piece Arterial Cannula Blunt, intended for use with cardiopulmonary, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2807-2026
- FDA event ID
- 99320
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2026
- FDA classified
- 27 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 24 Jun 2026 | Recall initiated by company | |
| 27 Jul 2026 | Classified by FDA | +33 days |
| 5 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Is Eopa Elongated One-Piece Arterial Cannula Blunt, intended for use with cardiopulmonary recalled?
Yes. Medtronic Perfusion Systems recalled Eopa Elongated One-Piece Arterial Cannula Blunt, intended for use with cardiopulmonary on 24 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2807-2026.
Why was it recalled?
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Which lots are affected?
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
Where was it sold?
Worldwide - US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Perfusion Systems
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula DIL TIP, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA 3D Arterial Cannula, intended for use recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
| Device | CLASS II | EOPA Elongated One-Piece Arterial Cannula DIL TIP recalled | Medtronic Perfusion Systems | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |