Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88334

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

Open FDA event record

Event summary

Timeline bucket
July 14, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ostial Corporation

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

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Z-2309-2021
Recall number
Z-2309-2021
Initiated
July 14, 2021
Classification
Class II
Status
Terminated
Recalling firm
Ostial Corporation
Quantity
40

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.

Code information

Lot: 82210399

Distribution pattern

US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.