CLASS II Device recall · Reported 15 Oct 2014 · FDA Enforcement Report
Biosense Webster's Reprocessed Soundstar¿ eco Diagnostic recalled
Sterilmed is recalling Biosense Webster's Reprocessed Soundstar¿ eco Diagnostic Ultrasound Catheters, distributed in California, Washington. The recall was initiated on 24 Sep 2014 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-0059-2015
- FDA event ID
- 69337
- Recalling firm
- Sterilmed, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2014
- FDA classified
- 9 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 24 Sep 2014 | Recall initiated by company | |
| 9 Oct 2014 | Classified by FDA | +15 days |
| 15 Oct 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
Product as listed by the FDA
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Where it was distributed
US Distribution including the states of WA and CA.
Questions about this recall
Why was it recalled?
Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasound Catheters for which Sterilmed is the reprocessor and Biosense Webster is the distributor. Sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne
Which lots are affected?
Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577
Where was it sold?
US Distribution including the states of WA and CA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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