Recall Z-0505-2018— Cardiovascular Systems Inc

Name: FDA recall Z-0505-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-14

Class II · Terminated

Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2017-09-14, terminated 2019-11-04. It names one FDA 510(k) clearance: K152694. 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: 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..

Recalling firm: Cardiovascular Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2017-09-14
Terminated: 2019-11-04
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K152694 — Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.·cleared 2015-10-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.