Z-1230-2017Class II

DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is...

Name: Z-1230-2017 DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is...
Creator: Cardiovascular Systems Inc
Published: 2016-12-07
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2016-12-07 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems Inc began a recall of DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed... on 2016-12-07. FDA classified it as Class II and gives the reason as "CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1230-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-07
Posted: 2017-02-22
Terminated: 2017-03-23
Recalling firm: Cardiovascular Systems Incorporated
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 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.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Cardiovascular Systems, Inc. sent an Urgent Medical Device Recall letter, dated 12/07/2016, to all affected customers. The letter identified affected product , stated the reason for recall, asked for product to be returned to CSI. Questions can be directed to Customer Service at 877-274-0901.
Quantity in commerce: 8 units
Distribution: Nationwide Distribution to LA, MS, SC, TX
Product codes and lots: Lot: 171686, Expiration: 2018-09-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1230-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1230-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code MCW

K152694Class IIDiamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. / cleared 2015-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)