Z-0507-2020Class II

The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant...

Name: Z-0507-2020 The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant...
Creator: Nucryo Vascular Inc.
Published: 2019-10-11
License: https://open.fda.gov/license/

Nucryo Vascular Inc. / initiated 2019-10-11 / Terminated / root cause: labeling and UDI

FDA source

Nucryo Vascular Inc. began a recall of The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon... on 2019-10-11. FDA classified it as Class II and gives the reason as "Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0507-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Posted: 2019-11-21
Terminated: 2021-05-03
Recalling firm: Nucryo Vascular Inc.
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.
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0507-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0507-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code LIT

K152665Class IIPolarCath Peripheral Dilatation SystemNucyro Vascular, LLC / cleared 2015-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)