CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Medtronic DLP Coronary Ostial Cannulae recalled
Medtronic Perfusion Systems is recalling Medtronic DLP Coronary Ostial Cannulae. The recall was initiated on 19 Mar 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-1795-2024
- FDA event ID
- 94274
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2024
- FDA classified
- 10 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 19 Mar 2024 | Recall initiated by company | |
| 10 May 2024 | Classified by FDA | +52 days |
| 22 May 2024 | 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
Potential for unsealed sterile packing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Potential for unsealed sterile packing.
Which lots are affected?
GTIN 00613994576019, Lot Numbers: 2023070529; GTIN 20613994576013, Lot Numbers: 2023070529
Where was it sold?
Worldwide 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
12 other products · FDA event 94274This product is part of a recall event; the main page for the event is Medtronic Disposable Pressure Display Sets: a) DLP¿ recalled.
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 6,199| 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 |