medical MODERATE Updated 2024-11-13

Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Mode

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Recalled Product

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

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Hazard / Issue

There is discrepant labeling on the inner and outer packaging of the device.

Issued by

FDA

Distribution: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
Lot/Code Info: UDI-DI: 10607567107974; Lot Number: 3000344298

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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