Soprano AEHA35Recalls & reported problems
Coloplast A/S · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040326725), received between Apr 29, 2024 and Apr 29, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
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
- Device Damaged by Another Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2024Device Damaged by Another Device; Device Damaged by Another Device
ACCORDING TO THE AVAILABLE INFORMATION THE HYDROPHILIC TIP APPEARED TO HAVE SHEARED OFF THE WIRE. IT IS BELIEVED THAT THE LASER FIBERS CAME IN CONTACT WITH THE HYDROPHILIC TIP OF THE WIRE AND FRAYED IT SLIGHTLY DURING THE PROCEDURE. THE TIP WAS NOT SEEN VIA X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 19201875 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
- HiWire G30474Cook Incorporated · Endoscopic guidewire, gastroenterology-urology82 reports
- 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.