The Recall Desk

FDA (Devices) recall action 81882

Volcano Corporation recalled 2 products on 2019-01-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-01-23
Critical
0
Units
8,110

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2019-01-23

    Volcano Visions PV .035 Digital IVUS Catheter Recall for Guidewire Issue

    Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

    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 cyli
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-01-23

    Volcano Visions PV .035 Digital IVUS Catheter Recalled for Guidewire Issue

    Volcano Corporation is recalling Visions PV .035 Digital IVUS Catheters because the guidewire may not pass through the y-port.

    Product
    Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 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 cyli
    Category
    Distribution
    0 states