Home / Recalls / Cardiovascular Systems, Inc. / Z-2155-2014

Z-2155-2014 Class I Terminated

Recalled by Cardiovascular Systems, Inc. — Saint Paul, MN

FDA device recall Z-2155-2014 was initiated by Cardiovascular Systems, Inc. on May 23, 2014 and is designated Class I. Reason for recall: CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during… The recall status is terminated (terminated Oct 1, 2014). Affected quantity: 48.

Recall Details

Product Type: Devices
Report Date: Aug 20, 2014
Initiation Date: May 23, 2014
Termination Date: Oct 1, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 48

Product Description

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 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.

Reason for Recall

CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.

Distribution Pattern

Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.

Code Information

100573, 100575, 100674, 100676, 100678, 100680.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2155-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Cardiovascular Systems, Inc.

Z-0394-2022 Class I — WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval… (Nov 22, 2021)
Z-2385-2021 Class II — DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM… (Jul 21, 2021)
Z-2386-2021 Class II — STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM… (Jul 21, 2021)
Z-3021-2018 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part… (Apr 13, 2018)
Z-0505-2018 Class II — Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system… (Sep 14, 2017)
Z-0506-2018 Class II — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system… (Sep 14, 2017)
Z-2122-2017 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part… (Apr 14, 2017)
Z-1771-2017 Class II — ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18… (Mar 3, 2017)
Z-1877-2017 Class II — ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number… (Feb 9, 2017)
Z-1230-2017 Class II — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral… (Dec 7, 2016)