Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System because the outer layer may flake off, potentially causing a flow-limiting embolism.
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: "The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the…"
Plain-English summary
Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System, Model Number DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
The recall is due to a defect where the OAD saline sheath outer layer may flake off from the catheter. This flaking can occur due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the flaked material is large enough, it has the potential to cause a flow-limiting embolism.
The affected units were distributed nationwide, including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI. The specific lot codes associated with this recall are 107046, 106992, 106993, and 106990. Healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. 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 de novo, severely calcified coronary…
- Manufacturer
- Cardiovascular Systems, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 30
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 (4)
- 107046
- 106992
- 106993
- 106990.
Distribution
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