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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76928

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

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Event summary

Timeline bucket
February 09, 2017
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 with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

Z-1877-2017
Recall number
Z-1877-2017
Initiated
February 09, 2017
Classification
Class II
Status
Terminated
Quantity
595

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.

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

CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.

Code information

Lot #: 175069, 175070, 176255

Distribution pattern

US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA