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.
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: 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.
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