Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices
Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural defect in a medical device that could lead to device failure (crown detachment) during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Cardiovascular Systems, Inc. has initiated a recall of 27 units of the CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. The affected devices are sterilized with Ethylene Oxide and are part of the Stealth 360-degree Orbital PAD system, which is indicated for use in patients with occlusive atherosclerotic disease in peripheral arteries.
The recall is being conducted because specific lot numbers of these devices have the potential for an insufficient crown solder bond. This defect may result in the crown becoming detached from the driveshaft during use. The affected lot numbers are 59887, 59888, 61516, and 61517.
The devices were distributed nationwide, including in California, Florida, Illinois, Michigan, Minnesota, Pennsylvania, and Texas. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 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 Orb
- Manufacturer
- Cardiovascular Systems, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot s: 59887
- 59888
- 61516
- and 61517.
Distribution
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