Z-0059-2015Class II

Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model...

Name: Z-0059-2015 Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model...
Creator: Sterilmed, Inc.
Published: 2014-09-24
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2014-09-24 / Terminated / root cause: manufacturing process

FDA source

STERILMED, INC. began a recall of Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577 on 2014-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0059-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Posted: 2014-10-09
Terminated: 2015-08-11
Recalling firm: Sterilmed Inc
Product: Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Product code: OWQ Reprocessed Intravascular Ultrasound Catheter
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.
Quantity in commerce: 22
Distribution: US Distribution including the states of WA and CA.
Product codes and lots: Lot Numbers: 1717945, 1721574, 1721575 and 1723123 Catalog Nos: M-5723-115, Model Number BIO10438577

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0059-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-15	2014-10-09

Product code OWQ

K110076Class IIReprocessed 3D Diagnostic Ultrasound CatheterSterilmed, Inc. / cleared 2011-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)