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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80765

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

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Event summary

Timeline bucket
April 13, 2018
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

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems 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 systems are percutaneous orbital atherectomy systems indicated as therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. Coronary: The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions

Z-3021-2018
Recall number
Z-3021-2018
Initiated
April 13, 2018
Classification
Class II
Status
Terminated
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.

Code information

Lot 126925, 168143, 127026, 146337, 171566, 148400, 182537, 154011, 54512A, 62814B, 124927, 145946, and 127026

Distribution pattern

US Nationwide Distribution in the states of AZ, CA, FL, GA, IL, MO, and TX