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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76352

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

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Event summary

Timeline bucket
December 07, 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

DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system 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 system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

Z-1230-2017
Recall number
Z-1230-2017
Initiated
December 07, 2016
Classification
Class II
Status
Terminated
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

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Inspect official wording and provenance

Reason for recall

CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

Code information

Lot: 171686, Expiration: 2018-09-30

Distribution pattern

Nationwide Distribution to LA, MS, SC, TX