Exact FDA event identifier

Event 69049

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

Open FDA event record

Event summary

Timeline bucket: August 13, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Volcano 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

Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.

Z-2636-2014

Recall number: Z-2636-2014
Initiated: August 13, 2014
Classification: Class II
Status: Terminated
Recalling firm: Volcano Corporation
Quantity: 8251 total devices (3777 US)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

breach to the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

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Inspect official wording and provenance

Reason for recall

Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.

Code information

Part number 91003: All Lots

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.