NA R10438577Recalls & reported problems
Sterilmed, Inc. · REPROCESS SDSTR ECO 10F-90 SMS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551044356), received between Nov 12, 2020 and May 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K110076); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- No Display/Image1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A SOUNDSTAR® ECO 10F DIAGNOSTIC ULTRASOUND CATHETER AND THERE WAS A PIECE OF WHITE TAPE OR DEBRIS STUCK ON THE SHAFT OF THE CATHETER, APPROXIMATELY 12 INCHES FROM THE CATHETER TIP. THE TAPE/DEBRIS WAS NOT BELIEVED TO BE THE TRANSITIONAL PIECE WHICH IS A WHITE LABEL. THE STERILITY OF THE CATHETER WAS QUESTIONABLE. THE CATHETER WAS EXCHANGED TO CONTINUE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298389 ↗MalfunctionNov 12, 2020No Display/Image
ICE SHOWED NO IMAGES INSIDE BODY AND IN SALINE. TRIED REPLUGGING AND RE-INITIATION, AND IT STILL DID NOT WORK.
Patient problems: Insufficient Information
MAUDE report 10828661 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K110076. One submission often covers many models, so check the product and lot details in each record.
- Z-0059-2015 · Sep 24, 2014 · TerminatedBiosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Other Reprocessed intravascular ultrasound catheter devices
- MEDLINE D087031RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls5 reports
- MEDLINE 10135910RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- MEDLINE 10135936RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
- MEDLINE 10438577RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439236RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439011RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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