CLASS II ONGOING Device recall · Reported 29 Jan 2025 · FDA Enforcement Report
EOPA Arterial Cannula recalled by Medtronic Perfusion Systems
Medtronic Perfusion Systems is recalling EOPA Arterial Cannula, distributed nationwide in the US. The recall was initiated on 12 Dec 2024 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-0985-2025
- FDA event ID
- 96015
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Dec 2024
- FDA classified
- 17 Jan 2025
- Reported
- 29 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 12 Dec 2024 | Recall initiated by company | |
| 17 Jan 2025 | Classified by FDA | +36 days |
| 29 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Product as listed by the FDA
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Which lots are affected?
Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96015This product is part of a recall event; the main page for the event is DLP Pediatric One-Piece Arterial Cannulae recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DLP Pediatric One-Piece Arterial Cannulae recalled | Medtronic Perfusion Systems | Labeling Errors | Nationwide | |
| CLASS II | Select Series Angled Tip Arterial Cannula recalled | Medtronic Perfusion Systems | Labeling Errors | Nationwide |
More recalls from Medtronic Perfusion Systems
All 116| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eopa Elongated One-Piece Arterial Cannula Blunt 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 |
| 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 |
Other Heart & Vascular Devices recalls
All 6,217| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |