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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 8
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
Part of a larger recall action
This product is one of 2 recalled by Cardiovascular Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Cardiovascular Systems Inc
See all →- SevereWIRION Embolic Protection System Filter Withdrawal Difficulties
FDA (Devices) · 2021-12-29
- HighDiamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall
FDA (Devices) · 2021-09-08
- HighCardiovascular Systems Recalls Orbital Atherectomy Saline Infusion Pumps
FDA (Devices) · 2018-09-19
- ModerateCardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
FDA (Devices) · 2018-02-14
- ModerateCardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
FDA (Devices) · 2018-02-14
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
Similar recalls
- ModerateCardiovascular Systems Recalls Mislabelled Diamondback 360 Peripheral Atherectomy Components
FDA (Devices) · 2017-03-01
- ModerateCardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
FDA (Devices) · 2018-02-14
- HighCardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error
FDA (Devices) · 2017-05-03
- HighCardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices
FDA (Devices) · 2012-07-18
- ModerateEmbolization devices recalled due to incorrect labeling of implant dimensions
FDA (Devices) · 2026-07-29
- SevereCardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System
FDA (Devices) · 2014-08-20