Cardiovascular Systems Recalls Peripheral Diamondback Atherectomy Systems Due to Labeling Error
Cardiovascular Systems Inc. is recalling eight units of the Peripheral Diamondback 1.25 Solid OAD system because labeling for two lots was potentially switched during production.
What this means for you
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 explicitly attributes the recall to a labeling error without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardiovascular Systems, Inc. (CSI) is voluntarily removing the Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system, from the market. The recall involves eight units of the device, which is indicated for the treatment of occlusive atherosclerotic disease in peripheral arteries.
The recall was initiated because it was identified that the labeling for two lots of the product was potentially inadvertently switched during production. The affected units are identified by Lot # 190097, Part # 7-10012, and Model # DBP-125SOLID145.
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 contact Cardiovascular Systems, Inc. for further information regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- Peripheral Diamondback 1.25 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 # 190097 Part #: 7-10012 Model # DBP-125SOLID145
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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