Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy Devices
Cardiovascular Systems, Inc. is recalling 318 Diamondback 360 Coronary Orbital Atherectomy Devices because they mistakenly contain a saline line not approved for coronary use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which indicates a low risk of adverse health consequences. The issue is a component specification error (incorrect saline line) rather than a direct, immediate hazard like a structural failure or contamination, fitting the criteria for a moderate severity score.
Plain-English summary
Cardiovascular Systems, Inc. has initiated a recall to request the immediate removal and return of the Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The recall affects 318 units of the device, identified by Part Number 70058-02 and Model Number DBEC-125.
The recall was initiated because the devices mistakenly contain a saline line that is used in the company's peripheral atherectomy device. This specific saline line was not part of the FDA approval for use in the coronary device and therefore does not meet the required specifications for this product.
The affected devices were distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Massachusetts, Minnesota, Mississippi, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare providers and facilities should immediately remove these devices from use and return them to the manufacturer.
The recalled product
- Product
- CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to…
- Manufacturer
- Cardiovascular Systems, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 318
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 (20)
- Lot: 85408 -85412
- 85585 -85587
- 87276
- 87278
- 87280
- 87317
- 87462
- 87464
- 87793
- 87949 - 87952
- 88520 - 88524
- 88975 - 88979
- 89498
- 89501- 89504
- 89952
- 89954
- 89956
- 91876
- 91877
- 91891
Distribution
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