DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimall
FDA device recall Z-1230-2017 · posted 2017-02-22 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems Inc
- Reason for recall
- CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
- Action taken
- Cardiovascular Systems, Inc. sent an Urgent Medical Device Recall letter, dated 12/07/2016, to all affected customers. The letter identified affected product , stated the reason for recall, asked for product to be returned to CSI. Questions can be directed to Customer Service at 877-274-0901.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 8 units
- Distribution
- Nationwide Distribution to LA, MS, SC, TX
- Date initiated
- 2016-12-07
- Date posted
- 2017-02-22
- Date terminated
- 2017-03-23
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Diamondback 360 Peripheral Orbital Atherectomy System (K152694) | Cardiovascular Systems, Inc. | 2015-10-21 |