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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74445

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

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Event summary

Timeline bucket
June 13, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardiovascular Systems 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

ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.

Z-2051-2016
Recall number
Z-2051-2016
Initiated
June 13, 2016
Classification
Class II
Status
Terminated
Quantity
190 units (38 - 5 pack shelf cartons)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label was missing

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The pouch label was missing the use by date (UBD) of 2018-04.

Code information

Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.

Distribution pattern

US Nationwide distribution.