FDA recall Z-0505-2018

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.

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-09-14

Report date

2018-02-14

Termination date

2019-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0505-2018