The Recall Desk

Manufacturer

Cardiovascular Systems, Inc.

15 recalls in our database name Cardiovascular Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
1
Most recent
2021-12-29

Of the 15 recalls from Cardiovascular Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • SevereFDA (Devices)·Z-0394-2022·2021-12-29

    WIRION Embolic Protection System Filter Withdrawal Difficulties

    Cardiovascular Systems Inc recalls WIRION Embolic Protection System devices (6Fr) because the filter assembly may become difficult to withdraw, and the device may tear or separate, creating a risk of blood clot embolization.

    Product
    WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2385-2021·2021-09-08

    Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall

    Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.

    Product
    DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2021·2021-09-08

    Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling

    Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.

    Product
    STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3021-2018·2018-09-19

    Cardiovascular Systems Recalls Orbital Atherectomy Saline Infusion Pumps

    Cardiovascular Systems Inc is recalling 18 Orbital Atherectomy System Saline Infusion Pumps because they may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    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 indepen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    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.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0505-2018·2018-02-14

    Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error

    Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.

    Product
    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.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2122-2017·2017-05-31

    Cardiovascular Systems Recalls Orbital Atherectomy System Saline Infusion Pumps

    Cardiovascular Systems Inc. is recalling 1,396 Saline Infusion Pumps that may switch to stand-by during use, requiring a reset to continue treatment.

    Product
    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1877-2017·2017-05-03

    Cardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error

    Cardiovascular Systems Inc is recalling 595 units of ViperWire Advance guide wires because 0.018-inch products were packaged as 0.014-inch.

    Product
    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 i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1771-2017·2017-04-19

    Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Sizing Error

    Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance Peripheral Guide Wires because they may contain the wrong size product.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2017·2017-03-01

    Cardiovascular Systems Recalls Mislabelled Diamondback 360 Peripheral Atherectomy Components

    Cardiovascular Systems Inc is recalling 8 units of the Diamondback 360 Peripheral 1.50 Classic system because a 1.50mm Solid Crown OAD was mislabeled as a 1.50mm Crown OED.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2051-2016·2016-07-06

    Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Missing Date

    Cardiovascular Systems Inc is recalling ViperWire Advance Peripheral Guide Wire because the pouch label was missing the use-by date.

    Product
    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 Diamond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1290-2015·2015-04-01

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System because the outer layer may flake off, potentially causing a flow-limiting embolism.

    Product
    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 arter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2014·2014-08-20

    Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.

    Product
    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 pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2014·2014-03-05

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 318 Diamondback 360 Coronary Orbital Atherectomy Devices because they mistakenly contain a saline line not approved for coronary use.

    Product
    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 d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2012·2012-07-18

    Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.

    Product
    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 Orb
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Cardiovascular Systems (United States)

company in Saint Paul, United States

Country
United States
Founded
1989

Official website

Source: Wikidata (Q30291564), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.