CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized wi
FDA device recall Z-1959-2012 · posted 2012-07-09 · Terminated
Recall details
- Recalling firm
- Cardiovascular Systems, Inc.
- Reason for recall
- CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
- Action taken
- Phone calls to affected sites began June 15, 2012 to quarantine the product. These same sites were also notified with an Urgent Medical Device Recall letter, dated June 18, 2012, via FedEx and e-mail (where available) on June 18, 2012. The letter notified each customer to remove from use and return the recalled product. The customer was instructed to complete a Customer Acknowledgement Form and return it with the device(s) being returned in the Returned Goods Authorization kit provided. Customers with questions can contact customer service at 1-877-274-0901. For any questions regarding this recall call 651-259-2805.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 27
- Distribution
- Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
- Date initiated
- 2012-06-18
- Date posted
- 2012-07-09
- Date terminated
- 2012-07-19
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTH 360 ORBITAL PAD SYSTEM (K110389) | Cardiovascular Systems, Inc. | 2011-03-11 |