PILLING IPN029214Recalls & reported problems
Teleflex Incorporated · MALONEY TUNGSTEN FILLED BOUGIE 36 FRENCH · Class 2
All models of PILLING (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704642226), received between May 3, 2024 and Sep 13, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED "BOUGIE WAS REMOVED FROM THE STOCK HOLDING TO BE PROCESSED FOR AN AFTERNOON LIST. STAFF NOTICED THAT WHEN CHECKING THE BOUGIE PRIOR TO STERILIZATION THAT THE EXPIRY DATE WAS ILLEGIBLE TO READ. THE BOUGIE EXPIRY DATE IS CHECKED ROUTINELY PRIOR TO EACH STERILIZATION PROCESS. BOUGIES CAN NOT BE USED ON A PATIENT IF EXPIRY IS NOT LEGIBLE". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212109 ↗MalfunctionMay 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED "INSTRUMENT USED BY DATE STAMP HAS COME OFF THE BOUGIE AND CSSD ARE NOW UNABLE TO STERILISE AS UNABLE TO DETERMINE CORRECT USED BY DATE IN ACCORDANCE WITH MANUFACTURING GUIDELINES". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19254509 ↗MalfunctionMay 3, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED " INSTRUMENT USED BY DATE STAMP HAS COME OFF THE BOUGIE AND CSSD ARE NOW UNABLE TO STERILISE AS UNABLE TO DETERMINE CORRECT USED BY DATE IN ACCORDANCE WITH MANUFACTURING GUIDELINES ". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243483 ↗
Other Bougie, esophageal, and gastrointestinal, gastro-urology devices
- M-Flex® 1206-54Diversatek Healthcare, Inc. · Bougie, Esophageal, And Gastrointestinal, Gastro-Urology1 report
- PILLING IPN029212Teleflex Incorporated · Bougie, esophageal, and gastrointestinal, gastro-urology1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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