# FDA recall Z-0505-2018

> **Cardiovascular Systems Inc** · Class II · device recall initiated 2017-09-14.

## 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

- **Recall number:** Z-0505-2018
- **Recalling firm:** Cardiovascular Systems Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0505-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0505-2018. Source: US FDA. Licensed CC0.

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