GYRUS ACMI 70241314Recalls & reported problems

Gyrus ACMI, LLC · COLLAR BUTTON VENT TUBE DISPENSER PACK - 30 UNITS 1.27MM ID ULTRASIL SILICONE · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 13
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00821925032040), received between Aug 29, 2019 and Aug 30, 2019 — classified as 13 injuries.

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 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem13

Patient problems

Unspecified Infection13

Recent adverse event reports

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

InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 6 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8951153 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6)2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867*. COMPLAINT 2 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950923 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867*. COMPLAINT 15 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950815 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 14 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950716 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 13 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950653 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 11 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950379 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 10 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950186 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 9 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8950070 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 7 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8949721 ↗
InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 5 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8948459 ↗
InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT NUMBER 4 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8948360 ↗
InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440. SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867. COMPLAINT 3 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8948333 ↗
InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY REPRESENTATIVE REPORTED A TOTAL OF 15 CASES OF PATIENT INFECTIONS SINCE (B)(6) 2019 FOR THE SAME FACILITY. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # LZ845980. TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC740479 TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # MH693598 TWO CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # S835440 SEVEN CASES OF INFECTIONS ON THIS 70241314 VENT TUBE WITH LOT # NC785867 COMPLAINT 1 OF 15.
Patient problems: Unspecified Infection
MAUDE report 8948290 ↗

Device details

UDI-DI	`00821925032040`
Brand	GYRUS ACMI
Model	70241314
Company	Gyrus ACMI, LLC
Product code	ETD · TUBE, TYMPANOSTOMY
Class	Class 2
FDA submission	K960477
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 2, 2024

Device type (GMDN): Tympanostomy tube

A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

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All TUBE, TYMPANOSTOMY devices →

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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