M-Flex® 1206-54Recalls & reported problems
Diversatek Healthcare, Inc. · Blue Silicone Tungsten Maloney Esophageal Dilator, 54 French · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00816734020173), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
InjuryJun 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
PER SUS VOLUNTARY EVENT REPORT MW5101618 FROM (B)(6): "ENDOSCOPY BOUGIE BEING USED IN SURGICAL CASE WAS BEING REMOVED WHEN THE TIP CAME OFF. THE TIP WAS RETRIEVED, HOWEVER, TUNGSTEN POWDER FROM THE BOUGIE WAS NOTED IN THE PT'S MOUTH."
Patient problems: Foreign Body In Patient
MAUDE report 12078869 ↗
Other Bougie, Esophageal, And Gastrointestinal, Gastro-Urology devices
- PILLING IPN029214Teleflex Incorporated · Bougie, esophageal, and gastrointestinal, gastro-urology3 reports
- 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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