Exact FDA event identifier

Event 84134

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: October 11, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Nucryo Vascular Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0507-2020

Recall number: Z-0507-2020
Initiated: October 11, 2019
Classification: Class II
Status: Terminated
Recalling firm: Nucryo Vascular Inc.
Quantity: 49

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.

Code information

Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758

Distribution pattern

U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution