EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endo
FDA device recall Z-0864-2016 · posted 2016-02-24 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
- Action taken
- All affected consignees were contacted by telephone January 20- 22, 2016. The URGENT VOLUNTARY PRODUCT RECALL letter, dated January 21, 2016, was sent to consignees. Consignees were advised that replacement devices were shipped to their facility on January 21, 2016 and should arrive there on January 22, 2016. Consignees with questions can call: Jocelyn Kersten Vice President, Regulatory and Clinical Affairs EKOS Corporation, a BTG International Group Company 425-415-3132 Jocelyn.kersten@ekoscorp.com
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 10 units
- Distribution
- Distributed in the states of AZ, CA, MA, MI, OH, and VA.
- Date initiated
- 2016-01-21
- Date posted
- 2016-02-24
- Date terminated
- 2016-03-15
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT (K140151) | Btg International, Inc. | 2014-05-21 |
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |