EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150
FDA device recall Z-2023-2012 · posted 2012-07-17 · Terminated
Recall details
- Recalling firm
- EKOS Corporation
- Reason for recall
- EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.
- Action taken
- Starting May 25, 2012 to May 31, 2012, EKOS Corporation sent "New warnings in EkoSonic Endovascular Device Instruction for Use" letter, dated May 24, 2012, to all affected customers. Attached with the notification letter is the revised EKOS MACH4 Endovascular Device Instructions for Use in Peripheral Vasculature. Customers are informed of the complaints about the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and reports of the MicroSonic Device (MSD) breaking during insertion or operation. Customers with questions about the revised Instruction for Use, please contact EKOS Corporation at 425-415-3132.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 21,892 units
- Distribution
- Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, R
- Date initiated
- 2012-05-24
- Date posted
- 2012-07-17
- Date terminated
- 2012-11-20
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EKOSONIC ENDOVASCULAR SYSTEM (K111705) | Ekos Corporation | 2011-08-03 |
| EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION (K081467) | Ekos Corp. | 2008-06-26 |