Reported Sep 9, 2015 · Terminated
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular:…
Volcano Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corporation · 2870 Kilgore Rd · Rancho Cordova, CA · 95670-6133
Is this the product you have?
- Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions
- CardiovascularThe Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature
- Lot codes and dates
- Product Code PPLUS20; All lots
- Amount recalled
- 5042 devices
Where it was sold
- Nationwide
Why it was recalled
Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters.
This product could cause temporary or reversible health problems — stop using it.
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