medical MODERATE Updated 2019-01-23

Volcano Corporation recalls Visions PV .035 Digital IVUS Catheter, Catalog Number/Part N

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Recalled Product

Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultrasound transducer on the distal tip. The transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The devices are provided sterile and are single use disposable devices.

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Hazard / Issue

Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to the potential inability to pass the guidewire through the y-port of the catheter.

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: Batch Numbers: 0301438588 0301450806 0301457390 0301457394 0301461995 0301487960 0301457393 0301450808 0301435421 0301442654 0301446201 0301469590 0301469593 0301442649 0301446202 0301476726 0301480937 0301485800 0301465886 0301498206 0301420742 0301485801 0301441407 0301469591 0301465885 0301476727 0301450809 0301480927 0301453527 0301440822 0301450812 0301453524 0301461996 0301476725 0301480928 0301492147 0301422648 0301450811 0301461999 0301450810 0301430794 0301430795 0301446203 0301472637 0301430796 0301465887

✅ 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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