Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use."
Plain-English summary
Cardiovascular Systems, Inc. has initiated a recall of the Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The recall involves 48 units distributed nationwide, including in Arizona, Arkansas, California, Connecticut, Florida, Illinois, Iowa, Maryland, Michigan, New York, North Carolina, Pennsylvania, Tennessee, and Texas. The affected units are identified by the following codes: 100573, 100575, 100674, 100676, 100678, and 100680.
The recall was initiated because the device may contain a saline sheath that can experience cracking or fracture during use. This defect may result in the release of particulate matter. The device is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries, as well as for the removal of stenotic material from artificial arteriovenous dialysis fistulae and occluded hemodialysis grafts.
Healthcare providers and facilities should stop using the affected devices immediately. Users should contact Cardiovascular Systems, Inc. for instructions on returning the devices or obtaining replacements. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in…
- Manufacturer
- Cardiovascular Systems, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 48
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 (6)
- 100573
- 100575
- 100674
- 100676
- 100678
- 100680.
Distribution
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