Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.50 Solid OAD system because labeling for two lots was potentially switched during production.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardiovascular Systems Inc. (CSI) is voluntarily removing the Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system, from the market. The recall involves eight units of the device, which is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries who are acceptable candidates for percutaneous transluminal atherectomy.
The recall was initiated because it was identified that the labeling for two lots of the product was potentially inadvertently switched during production. The specific units involved are identified by Lot # 190217, Part # 7-10011, and Model # DBP-150SOLID145.
The affected devices were distributed to facilities in Florida, Illinois, Michigan, Minnesota, Missouri, New York, South Carolina, Texas, and Wisconsin. Healthcare providers and patients should verify the lot and model numbers of their devices against the recall information and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
- Manufacturer
- Cardiovascular Systems Inc
- Category
- Medical Device — Cardiovascular
- 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 # 190217 Part #: 7-10011 Model # DBP-150SOLID145
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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