Recall Z-2854-2016— EKOS Corporation
Class II · Terminated
Class II FDA medical device recall by EKOS Corporation, initiated 2016-08-09, terminated 2016-10-05. It names 3 FDA 510(k) clearances: K140151, K111705, K081467. Product: EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter. Reason: The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device..
- Recalling firm
- EKOS Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-09
- Terminated
- 2016-10-05
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
3 on FDA's record- K140151 — EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
- K111705 — EKOSONIC ENDOVASCULAR SYSTEM
- K081467 — EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Reason for recall
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.