The PolarCath Balloon Catheter consists of a coaxial recall: Labeling Error
The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip…
Why was The PolarCath Balloon Catheter consists of a coaxial recalled?
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758
- Product
- The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip…
- Recalling firm
- Nucryo Vascular Inc.
- Quantity
- 49
- Distribution
- U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
- Recall date
- November 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)