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Cardiovascular Systems, Inc.: Medical Device Recalls in 2012

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Cardiovascular Systems, Inc. in 2012. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2012
2014
2015
2016
2017
2018
2021
  • CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is 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.
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