CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
MEGA 7.. 40cc Intra-Aortic Balloon with Accessories recalled
Datascope is recalling MEGA 7.. 40cc Intra-Aortic Balloon with Accessories. The recall was initiated on 17 Sep 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-0311-2025
- FDA event ID
- 95396
- Recalling firm
- Datascope, Fairfield, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2024
- FDA classified
- 5 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 17 Sep 2024 | Recall initiated by company | |
| 5 Nov 2024 | Classified by FDA | +49 days |
| 13 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is discrepant labeling on the inner and outer packaging of the device.
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
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Where it was distributed
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Questions about this recall
Why was it recalled?
There is discrepant labeling on the inner and outer packaging of the device.
Which lots are affected?
UDI-DI: 10607567107974; Lot Number: 3000344298
Where was it sold?
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
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.
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