TaperGuard 18785SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521164550), received between May 15, 2017 and Sep 30, 2020 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (10 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S CUFF WAS TRIED TO INFLATE, BUT IT WAS UNABLE TO INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10609950 ↗
• InjuryAug 25, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WOULD NOT DEFLATE. IT WAS CUT FOR THE AIR TO COME OUT AND REPLACEMENT OF THE TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 10451535 ↗
• MalfunctionFeb 2, 2018Inflation Problem; Contamination of Device Ingredient or Reagent; Inflation Problem; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE REPORTER PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL LIKE VINYL POLYMERS WERE FOUND INSIDE THE PACKAGE BEFORE OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7235551 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081365 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081337 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081304 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081261 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081235 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081216 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081166 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081145 ↗
• MalfunctionDec 4, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7081106 ↗
• MalfunctionMay 15, 2017Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THE LABEL WAS MISSING DESCRIPTION SIZES AND DIAMETER MEASUREMENTS CUSTOMER INDICATED THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6568190 ↗