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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential to cause a flow-limiting embolism, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
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 arter
- 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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