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XprESS Ultra MSB&LLFRecalls & reported problems

Stryker Corporation · ENT Dilation System 6x20mm · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857326005123), received between Jun 21, 2018 and Sep 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Component Missing1
  • Failure to Shut Off1
  • Temperature Problem1

Patient problems

  • Inflammation1
  • No Code Available1
  • No Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA IN THE HEAD, NECK, AND CHEST. AFTER THE PHYSICIAN SUCCESSFULLY COMPLETED BILATERAL EUSTACHIAN TUBE DILATION, THE PATIENT WAS DISCHARGED HOME. ON POSTOPERATIVE DAY 1, THE PATIENT REPORTED SNEEZING VIGOROUSLY WHILE LIFTING 30 TO 40 LBS AT WORK AND SUBSEQUENTLY DEVELOPING BILATERAL FACIAL AND NECK SWELLING. THE PATIENT HAD A CAT SCAN AND WAS FOUND TO HAVE SUBCUTANEOUS EMPHYSEMA OF THE HEAD, NECK, AND CHEST WITH SIGNIFICANT PNEUMOMEDIASTINUM. PATIENT WAS PUT ON SINUS PRECAUTIONS (NO NOSE BLOWING, LIFTING >5 LBS, DRINKING THROUGH STRAWS, COUGHING, OR SNEEZING WITH MOUTH CLOSED). THE PATIENT'S SUBCUTANEOUS EMPHYSEMA IMPROVED OVER 48 HOURS WITHOUT INTERVENTION, AND THE PATIENT WAS DISCHARGED HOME. NO FURTHER PATIENT INJURY OR COMPLICATIONS HAVE BEEN REPORTED.

    Patient problems: Inflammation; No Code Available

    MAUDE report 7851535 ↗
  • InjuryJun 21, 2018Component Missing; Failure to Shut Off; Temperature Problem

    THE XPRESS ULTRA ENT DILATION SYSTEM, REF # (B)(4), LOT # A15246 IS BATTERY POWERED BY LITHIUM ION UNIT AND HAS NO SHUT OFF. THERE IS NO ACTION, SWITCH, KNOB TO TURN THE POWER OFF TO THE INSTRUMENT. THE SCRUB TECH NOTICED THE UNIT WAS HOT AFTER SURGERY.

    Patient problems: No Information

    MAUDE report 7628796 ↗

Other Eustachian Tube Balloon Dilation Device devices

All Eustachian Tube Balloon Dilation Device devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.