CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, P
FDA device recall Z-2155-2014 · posted 2014-08-14 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems, Inc.
- Reason for recall
- 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.
- Action taken
- Cardiovascular System, Inc. sent consignees an Urgent Medical Device Recall letter dated May 23, 2014. The letter described the Affected Product, Recall Description, Instructions which included to remove the affected product and return it to CSI and to complete and return the Customer Acknowledgement Form. For further Information they customers were instructed to contact Customer Service, Cardiovascular System, Inc., 877-274-0901. For questions regarding this recall call 877-274-0901.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 48
- Distribution
- Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
- Date initiated
- 2014-05-23
- Date posted
- 2014-08-14
- Date terminated
- 2014-10-01
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (K133399) | Cardiovascular Systems Incorporated | 2013-11-22 |