PlainRecalls

Cardiovascular Systems Inc

Compiled from official public sources by the publisher.

15 recalls on record · Latest: Dec 29, 2021

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Agency notice ledger

Federal filing book Cardiovascular Systems Inc LIGHT-BOOK · SINGLE-AGENCY

#1,016 of 14,151 · 15 notices · 0.014% archive

  • BOOK 15 notices
  • RANK #1,016 of 14,151
  • SHARE 0.014% archive
  • AGENCY FDA Devices (15)
  • CAT medical devices
  • CATS 1 category
  • LATEST Dec 29, 2021
  • PHOTO Acumed LLC

Nearest notice-volume peer: Acumed LLC (0 notice gap)

Cardiovascular Systems Inc accounts for about 0.014% of the 104,423-notice archive on 15 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Cardiovascular Systems Inc compares to 14,151 recalling firms

Cardiovascular Systems Inc ranks 1,016th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Cardiovascular Systems Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

15 1016th of 14151 higher than 13,088 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Cardiovascular Systems Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Cardiovascular Systems Inc holds about 0.014% of archive notices alongside 15 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Critical Dec 29, 2021

WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
FDA Devices Moderate Sep 8, 2021

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Devices Moderate Sep 8, 2021

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
FDA Devices Moderate Sep 19, 2018

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 orbi
FDA Devices Moderate Feb 14, 2018

Peripheral Diamondback 1.50 Solid OAD, 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.
FDA Devices Moderate Feb 14, 2018

Peripheral Diamondback 1.25 Solid OAD, 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.
FDA Devices Moderate May 31, 2017

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
FDA Devices Moderate May 3, 2017

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 mate
FDA Devices Moderate Apr 19, 2017

ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface f
FDA Devices Moderate Mar 1, 2017

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 li
FDA Devices Moderate Jul 6, 2016

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.
FDA Devices Critical Apr 1, 2015

Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is 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.
FDA Devices Critical Aug 20, 2014

CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. 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 arteriovenou
FDA Devices Low Mar 5, 2014

CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is 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.
FDA Devices Moderate Jul 18, 2012

CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree 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 trans

Cardiovascular Systems Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Acumed LLC 15 Aso LLC 15 Becton Dickinson Infusion Therapy Systems, Inc. 15 Bovie Medical Corporation 15

Frequently Asked Questions

How many federal recall notices name Cardiovascular Systems Inc? ▼
PlainRecalls indexes 15 distinct federal recall events naming Cardiovascular Systems Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Cardiovascular Systems Inc sit among other recalling firms? ▼
Cardiovascular Systems Inc ranks #1,016 of 14,151 by distinct recall-event count among 14,151 firms in this archive (92nd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Cardiovascular Systems Inc's notices? ▼
FDA Devices accounts for 15 of this firm's 15 indexed notices.
What product category dominates Cardiovascular Systems Inc's filing book? ▼
Filings for Cardiovascular Systems Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Cardiovascular Systems Inc: 15 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Cardiovascular Systems Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026