CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report
The EkoSonic Endovascular System employs high frequency recalled
EKOS is recalling The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power 585 watt. The recall was initiated on 2 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0133-2014
- FDA event ID
- 66504
- Recalling firm
- EKOS, Bothell, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2013
- FDA classified
- 1 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 2 Oct 2013 | Recall initiated by company | |
| 1 Nov 2013 | Classified by FDA | +30 days |
| 13 Nov 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
Where it was distributed
Worldwide Distribution in Germany only.
Questions about this recall
Is The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power 585 watt recalled?
Yes. EKOS recalled The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power 585 watt on 2 Oct 2013. The recall is Class II and its status is Terminated. Recall number Z-0133-2014.
Why was it recalled?
The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference.
Which lots are affected?
PT3B-783. PT3B represents the model number. Adding 783 creates the serial number.
Where was it sold?
Worldwide Distribution in Germany only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from EKOS
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | cart has recalled by EKOS | EKOS | Device Malfunction | Nationwide |
| Device | CLASS II | EkoSonic Endovascular Devices EKOS Intelligent Drug recalled | EKOS | Other | Nationwide |
| Device | CLASS II | EkoSonic Endovascular System recalled | EKOS | Sterility | 6 states |
| Device | CLASS II | EkoSonic Control Unit is intended exclusively for use recalled | EKOS | Sterility | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |