Cardiovascular Systems Recalls Mislabelled Diamondback 360 Peripheral Atherectomy Components
Cardiovascular Systems Inc is recalling 8 units of the Diamondback 360 Peripheral 1.50 Classic system because a 1.50mm Solid Crown OAD was mislabeled as a 1.50mm Crown OED.
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 involves a labeling error on a medical device with no reported illnesses or injuries, which aligns with the rubric for minor labeling errors and low-risk issues.
Plain-English summary
Cardiovascular Systems Inc is recalling 8 units of the DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System. The recall was initiated after the company discovered that a 1.50mm Solid Crown OAD was incorrectly labeled as a 1.50mm Crown OED.
The affected units are identified by Lot 171686 with an expiration date of September 30, 2018. The products were distributed nationwide to locations in Louisiana, Mississippi, South Carolina, and Texas.
The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a minimally invasive, catheter-based device designed to improve luminal diameter in patients with peripheral arterial disease. The source text does not report any illnesses or injuries associated with this mislabeling. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation…
- 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 (2)
- Lot: 171686
- Expiration: 2018-09-30
Distribution
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