Reported Nov 27, 2019 · Terminated
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems…
Nucryo Vascular Inc.
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: Nucryo Vascular Inc. · 2192 Bering Dr · San Jose, CA · 95131-2013
Is this the product you have?
- The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers.
- Lot codes and dates
- Lots
CAT 0738CAT 0739CAT 0740CAT 0743CAT 0744CAT 0746CAT 0750CAT 0751CAT 0758
- Lots
- Amount recalled
- 49
Where it was sold
Why it was recalled
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
This product could cause temporary or reversible health problems — stop using it.
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