medical LOW RISK Updated 2022-07-06

Volcano Corp recalls Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN:

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Recalled Product

Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

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Hazard / Issue

Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596

✅ 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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