Peripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling
Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.
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: This FDA Class II recall involves mislabeling of surgical device components that could affect device performance. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm medical device without reported adverse events receives a High (3) rating.
Plain-English summary
Cardiovascular Systems Inc is recalling certain STEALTH 360 GEN2 Peripheral Orbital Atherectomy System devices, specifically 1.25mm Micro Crown units with reference number PRD-SC30-MICRO. A total of 8 units have been identified as part of this recall (Lot 340931).
The recall is due to a potential mislabeling issue with orbital atherectomy device (OAD) crown sizes. Some units labeled as 1.25mm Micro Crown OADs may actually contain 1.50mm Sold Crown OADs, and vice versa. Using the incorrect size could affect device performance during the procedure.
The affected devices were distributed nationwide to medical facilities in Arkansas, Ohio, South Carolina, Washington, Pennsylvania, Wisconsin, Iowa, and Florida.
Healthcare providers and facilities with affected devices should stop use immediately and contact Cardiovascular Systems Inc for instructions on device return and replacement options.
The recalled product
- Product
- STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
- Manufacturer
- Cardiovascular Systems Inc
- Hazard
- mis-labeling
- size-mismatch
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 (1)
- Lot 340931
Distribution
Distributed nationwide across the United States.
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