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.
Recall
- Recall Number
- Z-0507-2020
- Event Number
- 84134
- Firm
- Nucryo Vascular Inc.
- FEI Number
- 3011393614
- Product Code
- LIT
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- October 11, 2019
- Terminated
- May 3, 2021
- Address
- 2192 Bering Dr, San Jose, CA, 95131-2013
Description
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.
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
On 10/11/19, Field Advisory Notices were mailed to customers informing them to check their inventory and return affected unused product. Further, customers were asked to complete and return the Field Action Response form. Customer service can be contacted at the following number , 408-541-1414.
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
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