NaviPro™ M00556250Recalls & reported problems
Lake Region Medical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729848240), received between Sep 18, 2024 and Sep 18, 2024 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT DESCRIPTION: AN ISSUE WE HAD WITH A NAVIPRO ON FRIDAY (B)(6) 2024. THE NAVIPRO WAS PUT DOWN BUT THEN UNABLE TO BE PULLED BACK AS IT HAD PEELED AWAY IN THE MIDDLE. THIS MEANT THE BRUSH COULD NOT BE USED AND THE WHOLE CANNULA HAD TO BE REMOVED. THE PATIENT UNFORTUNATELY HAD BEEN A DIFFICULT CANNULATION AND THEN HAD TO BE RE-CANNULATED. WE HAVE SAVED THE FAULTY NAVIPRO WHICH STILL HAS THE BRUSH ATTACHED AS THEY CANNOT BE SEPARATED. THE LOT NUMBER IS JRZ6586648. EXPIRY 31/08/2024. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: UNKNOWN. WHAT IS THE NEXT COURSE OF ACTION?: COLLECT DEVICE FOR TESTING. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. DEVICE ACQUIRED FROM A DISTRIBUTOR?: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20246047 ↗
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 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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