CLASS II Device recall · Reported 27 Nov 2019 · FDA Enforcement Report
The PolarCath Balloon Catheter consists of a coaxial recalled
Nucryo Vascular is recalling The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, distributed in Arkansas, California, Michigan, Mississippi, Oklahoma, Texas. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0507-2020
- FDA event ID
- 84134
- Recalling firm
- Nucryo Vascular, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2019
- FDA classified
- 21 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 11 Oct 2019 | Recall initiated by company | |
| 21 Nov 2019 | Classified by FDA | +41 days |
| 27 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Product as listed by the FDA
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.
Where it was distributed
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
Questions about this recall
Why was it recalled?
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Which lots are affected?
Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758
Where was it sold?
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |