Diamondback 360 Gen2 Orbital Atherectomy System Crown Size Mislabeling Recall
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System due to potential mislabeling of crown sizes. Units packaged as 1.50mm Solid Crown may actually be 1.25mm Micro Crown and vice versa.
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: FDA Class II medical device recall involving mislabeling of surgical device component sizes. No injuries or illnesses have been reported, but the mislabeling creates a risk-of-harm situation where incorrect device size selection could affect device performance during procedures.
Plain-English summary
Cardiovascular Systems Inc. is recalling 8 units of the Diamondback 360 Gen2 Peripheral Orbital Atherectomy System (Ref: DBP-150SOLID145, Lot 340925) due to a potential mislabeling of orbital atherectomy device (OAD) crown sizes.
The mislabeling involves 1.50mm Solid Crown OADs that may be packaged as 1.25mm Micro Crown OADs, and 1.25mm Micro Crown OADs that may be packaged as 1.50mm Solid Crown OADs. This packaging error could result in the wrong device size being selected and used.
The recalled units were distributed to medical facilities in Arkansas, Ohio, South Carolina, Washington, Pennsylvania, Wisconsin, Iowa, and Florida. No injuries or illnesses have been reported in association with this mislabeling.
This is a Class II recall by the FDA. Cardiovascular Systems Inc. initiated the recall.
The recalled product
- Product
- DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
- Manufacturer
- Cardiovascular Systems Inc
- Hazard
- 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 340925
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
- HighPeripheral Atherectomy Devices Recalled Due to Crown Size Mislabeling
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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02