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U.S. Department of Health and Human Services

Class 2 Device Recall PolarCath Peripheral Dilatation System

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  Class 2 Device Recall PolarCath Peripheral Dilatation System see related information
Date Initiated by Firm October 11, 2019
Create Date November 21, 2019
Recall Status1 Terminated 3 on May 03, 2021
Recall Number Z-0507-2020
Recall Event ID 84134
510(K)Number K152665  
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
Product 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.
Code Information Lots:  CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758
Recalling Firm/
Manufacturer		 Nucryo Vascular Inc.
2192 Bering Dr
San Jose CA 95131-2013
For Additional Information Contact
650-279-1653
Manufacturer Reason
for Recall		 Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 49
Distribution U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = NUCYRO VASCULAR, LLC
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