NaviPro™ M00556220Recalls & reported problems
Lake Region Medical · Class 2
Data updated Oct 18, 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 08714729848233), received between Nov 10, 2022 and Aug 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
- Packaging Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE WIRE OF THE ATRAUMATIC TIPS WAS DISENGAGED FROM THE GUIDEWIRE WHEN OPENED FROM THE PACKAGE BEFORE USE. 07 AUGUST 2025: 1. IMAGE RECEIVED. 2. WAS THE GUIDEWIRE HYDRATED OR RINSED WITH SALINE SOLUTION PRIOR TO REMOVAL FROM THE DISPENSER? NO, THE GUIDEWIRE WAS FOUND DEFECTIVE AFTER OPEN FROM THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912023 ↗MalfunctionNov 10, 2022Packaging Problem; Physical Resistance/Sticking
THE WIRE IS 'STUCK' IN THE PACKAGING. MULTIPLE ATTEMPTS WERE MADE TO FREE THE DEVICE FROM PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15770144 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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