TaperGuard 18775SRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521103856), received between May 4, 2017 and Jul 16, 2025 — classified as 1 death, 9 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN THE ENDOTRACHEAL TUBE WAS EXTUBATING THE AERATION ON THE CUFF COULD NOT BE REMOVED. BUT WHEN TRIED AGAIN AFTER TUBE REMOVAL, THE CUFF WAS DE-AERATED. THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 22523457 ↗
• MalfunctionApr 29, 2025Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT DURING USE WHEN CONNECTING TO CLOSED SUCTION, THE TUBE FREQUENTLY GOT DETACHED. THE TRACHEAL TUBE CONNECTOR WAS DISCONNECTED AND THE VENTILATOR ALARM SOUNDED, AND IT WAS PLUGGED IN AGAIN. REPLACEMENT WAS NOT PERFORMED UNTIL THE DAY OF SCHEDULED EXTUBATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931533 ↗
• MalfunctionFeb 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD A LEAK AFTER AN HOUR AND THIRTY MINUTES INTUBATED TO A PATIENT AS THE PRESSURE DECREASED WHEN CHECKED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21343381 ↗
• MalfunctionDec 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, DURING USE, THE ENDOTRACHEAL TUBE'S CUFF HAD DEFLATED. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 21034739 ↗
• MalfunctionNov 5, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A LOW-PRESSURE ALARM FROM THE RESPIRATORY SYSTEM RANG APPROXIMATELY 10 DAYS AFTER USE; WHEN THE CAUSE WAS CHECKED, A LEAK WAS FOUND FROM THE ENDOTRACHEAL TUBE'S CUFF, AND NO IMPROVEMENT WAS FOUND EVEN AFTER APPLYING PRESSURE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 20609985 ↗
• MalfunctionAug 8, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE ENDOTRACHEAL TUBE'S CUFF DEFLATED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941182 ↗
• MalfunctionJun 13, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF FORMED WRINKLES BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19527742 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN AN ATTEMPT WAS MADE TO EXTUBATE THE PATIENT ONE DAY AFTER STARTING OPE, THE AIR WAS REMOVED, BUT THE PILOT BALLOON DID NOT DEFLATE. APPARENTLY, THE PATIENT WAS EXTUBATED AS IT WAS BECAUSE IT WAS UNCLEAR WHETHER THE AIR IN THE CUFF HAD ESCAPED. THE TUBE WAS NOT REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19316215 ↗
• MalfunctionNov 22, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL INFLATION TUBE WAS FOUND COMPLETELY CRIMPED, PREVENTING CUFF INFLATION DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193393 ↗
• MalfunctionJun 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ENDOTRACHEAL TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165793 ↗
• MalfunctionApr 11, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ISSUE WITH DEFLATING THE CUFF FROM THE PILOT BALLOON DURING EXTUBATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714205 ↗
• MalfunctionFeb 9, 2022Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE 15MM CONNECTOR PIECE DETACHED FROM THE TUBE WHILE THE PATIENT WAS INTUBATED. THE PATIENT WAS REINTUBATED.

  Patient problems: Unintended Extubation

  MAUDE report 13502400 ↗
• MalfunctionJul 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED BUT THE CONDITION DID NOT IMPROVE AND THE PATIENT WAS EXTUBATED. THEN THE PATIENT WAS INTUBATED USING DIFFERENT DEVICE BUT THERE WAS A LEAK. CHEST X-RAY WAS PERFORMED BUT THERE WAS NO PROBLEM WITH THE POSITION. THE CUFF PRESSURE WAS RAISED TO 35CMH20 BUT IT DROPPED THEREAFTER BECAUSE OF THE LEAK. THE DEVICE WAS REMOVED AND WHEN CHECKED THERE WAS A DAMAGED PART. THE PATIENT WAS INTUBATED WITH A DIFFERENT DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 12200209 ↗
• MalfunctionJul 20, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED BUT THE CONDITION DID NOT IMPROVE AND THE PATIENT WAS EXTUBATED. THEN THE PATIENT WAS INTUBATED USING DIFFERENT DEVICE BUT THERE WAS A LEAK. CHEST X-RAY WAS PERFORMED BUT THERE WAS NO PROBLEM WITH THE POSITION. THE CUFF PRESSURE WAS RAISED TO 35CMH20 BUT IT DROPPED THEREAFTER BECAUSE OF THE LEAK. THE DEVICE WAS REMOVED AND WHEN CHECKED THERE WAS A DAMAGED PART. THE PATIENT WAS INTUBATED WITH A DIFFERENT DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 12200193 ↗
• MalfunctionJul 16, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181165 ↗
• MalfunctionJan 22, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD AN INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214913 ↗
• MalfunctionJan 15, 2021Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD AIR LEAK LEADING TO EMERGENT TUBE EXCHANGES WHICH HAVE OCCURRED THREE TIMES IN THE LAST WEEK. THIS WAS EXPERIENCED IN THE ICU ONLY.

  Patient problems: Unintended Extubation

  MAUDE report 11176029 ↗
• InjuryNov 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, AT DAY 5 OF INTUBATION, THERE WAS APPEARANCE OF CERVICAL EMPHYSEMA WITH PNEUMOMEDIASTINUM WHICH WAS OBJECTIFIED BY A CHEST SCANNER. INTUBATION WAS PERFORMED BY A SENIOR DOCTOR. RAS DURING THE GESTURE. WITH THE USE OF A REPLACEMENT TUBE, THERE WAS PRESENCE OF AN UNUSED STYLET REPLACED BY A DISPOSABLE STYLET (GLIDESCOPE). THE MECHANICAL VENTILATION WAS DISTURBED, PRESSURE BUILD-UP, HYPERCAPNIA AND VENTILATOR LEAKS AS CONSEQUENCE. THERE WAS NO EXTUBATION BECAUSE THE PATIENT WAS NOT SUFFICIENTLY STABLE, REGRESSION PROBABLE UNDER DRAINAGE. COMPLETE EVOLUTION UNKNOWN.

  Patient problems: Pulmonary Emphysema

  MAUDE report 10829106 ↗
• InjuryNov 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD INTUBATION ISSUE AND WAS REPORTED FOR THE GLIDESCOPE, THE STYLET AND THE TUBE. AT DAY+ 5 OF INTUBATION, THERE WAS APPEARANCE OF CERVICAL EMPHYSEMA WITH PNEUMOMEDIASTINUM (OBJECTIFIED BY CHEST SCANNER) AND HAD EXPERIENCED HYPERCAPNIA, NO EXTUBATION BECAUSE THE PATIENT IS NOT SUFFICIENTLY STABLE, REGRESSION PROBABLE UNDER DRAINAGE. COMPLETE EVOLUTION UNKNOWN. THE PATIENT HAD A COVID.

  Patient problems: Respiratory Failure

  MAUDE report 10828974 ↗
• InjurySep 14, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AN INTUBATED PATIENT IN ICU ON A VENTILATOR HAD TUBE LEAKAGE REQUIRING A REINTUBATION WITH NEW TUBE ON THE NEXT DAY.

  Patient problems: Extubate

  MAUDE report 10528352 ↗
• InjuryJul 28, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF HAD A LEAK. IT WAS INDICATED THAT THE DEVICE WAS REPLACED.

  Patient problems: Extubate

  MAUDE report 10335579 ↗
• MalfunctionJul 21, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE UNIT CUFF DID NOT INFLATE SYMMETRICALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10302548 ↗
• MalfunctionJul 1, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS AIR LEAKAGE FROM THE DEVICE'S CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10218947 ↗
• InjuryJun 24, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE PROCEDURE, ¿LEAK¿ INDICATION WAS NOTED ON THE ANESTHESIA DEVICE MONITOR, SO THE ANESTHESIOLOGIST CHECKED THE INTUBATION TUBE AND RESPIRATORY CIRCUIT. THERE WAS NO ABNORMALITY FOUND IN EITHER OF THEM, AND THE APPEARANCE OF THE INTUBATION TUBE WAS CHECKED USING A BRONCHOSCOPE. ALTHOUGH APPEARANCE ABNORMALITY WAS NOT FOUND, IT FELT LIKE THERE WAS A LEAK SOUND, SO THE INTUBATION TUBE WAS REPLACED. AFTER THAT, THE ¿LEAK¿ INDICATION ON THE ANESTHESIA DEVICE DISAPPEARED. IT WAS CONSIDERED THAT THE CAUSE OF THE LEAK WAS THE INTUBATION TUBE, BUT THE APPEARANCE OF THE TUBE AFTER REPLACEMENT WAS CHECKED AND NO OBVIOUS ABNORMALITY WAS OBSERVED.

  Patient problems: Extubate

  MAUDE report 10189660 ↗
• InjuryJun 18, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTUBATION WAS PERFORMED ON THE PATIENT WITHOUT PROBLEMS. TWO DAYS AFTER USING THE PRODUCT, LEAKAGE WAS NOTED. THE ISSUE WAS RESOLVED BY CHANGING THE TUBE. LUBRICANT WAS USED TO LUBRICATE THE TUBE BEFORE INSERTION. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 10167411 ↗