Soprano AEHB35Recalls & reported problems
Coloplast A/S · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03600040326756), received between Jun 28, 2024 and Nov 13, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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
- Material Fragmentation2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
ACCORDING TO THE AVAILABLE INFORMATION THE DEVICE WAS OPENED AND NOT USED DUE TO A HAIR INSIDE OF THE PEEL PACK. THIS WAS NOTICED BY THE SCRUB TECH AND THE PRODUCT WAS PUT ASIDE AND NOT USED. IT HAD NO PATIENT INTERACTION, AND NOBODY WAS HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544460 ↗InjuryJul 1, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE AVAILABLE INFORMATION THE HYDROPHILIC TIP SHEARED OFF AND WAS RETAINED IN THE PATIENT'S KIDNEY. THE TIP WAS REMOVED WITH A BASKET.
Patient problems: Insufficient Information
MAUDE report 19646511 ↗MalfunctionJun 28, 2024Material Fragmentation; Material Fragmentation
ACCORDING TO THE AVAILABLE INFORMATION THE DISTAL END OF THE WIRE BROKE OFF INSIDE THE PATIENT. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 19637975 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
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- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.