Z-0505-2018Class II

Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy...

Name: Z-0505-2018 Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy...
Creator: Cardiovascular Systems Inc
Published: 2017-09-14
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2017-09-14 / Terminated / root cause: labeling and UDI

FDA source

Cardiovascular Systems Inc began a recall of Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic... on 2017-09-14. FDA classified it as Class II and gives the reason as "Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0505-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-14
Posted: 2018-10-11
Terminated: 2019-11-04
Recalling firm: Cardiovascular Systems Incorporated
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.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 09/14/2017 the firm sent letters to their consignees explaining the recall and given the following instructions: Please immediately remove from use and return the affected Product Name devices to CSI. To do so: 1) Complete the attached Customer Acknowledgement Form a. Per lot, document the quantity of all devices that are to be returned. b. Per lot, document the quantity of all devices that have been consumed. 2) Place the Acknowledgement Form with the device 3) Return the device and Acknowledgement Form to CSI using the pre-paid FedEx label a. If you would like, a CSI Sales Representative can return the device and form. Please contact the CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgment Form per the above, and return the form to CSI in the provided FedEx envelope. Contact Information: [email protected] 651-259-2800 - Tel
Quantity in commerce: 8
Distribution: FL, IL, MI, MN, MO, NY, SC, TX, and WI
Product codes and lots: Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0505-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0505-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02
Z-0506-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02

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)