Cardiovascular Systems Inc: Medical Device Recall in 2018 - (Recall #: Z-0505-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 14, 2017

Date Posted: February 14, 2018

Recall Number: Z-0505-2018

Event ID: 78897

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.

Status: Terminated

Product Quantity: 8

Code Information:

Lot # 190097 Part #: 7-10012 Model # DBP-125SOLID145

Distribution Pattern:

FL, IL, MI, MN, MO, NY, SC, TX, and WI

Voluntary or Mandated:

Voluntary: Firm initiated