RUSCH IPN041898Recalls & reported problems

Teleflex Incorporated · Laryngectomy tube, cuffed · Class 2

All models of RUSCH (220)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704012909), received between Jan 17, 2024 and Jan 17, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loose or Intermittent Connection1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 17, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE CONNECTOR GOT DETACHED FROM THE TUBE BY ITSELF DURING USE ON A PATIENT, IMMEDIATELY AFTER INSERTION. THEREFORE, THE USER FIXED IT WITH ZIP TIE. NO INJURY TO THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526714 ↗

Device details

UDI-DI	`04026704012909`
Brand	RUSCH
Model	IPN041898
Catalog no.	121181-000070
Company	Teleflex Incorporated
Product code	BTO · Tube, tracheostomy (w/wo connector)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 24, 2023

Device type (GMDN): Laryngectomy tube

A hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Other Tube, tracheostomy (w/wo connector) devices

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Bivona 60SP040
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1 recall20 reports
Bivona 60SP050
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1 recall13 reports
Bivona 60P040
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall12 reports
Portex 101/860/070CZ
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60 reports
Bivona 60SP045
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall8 reports
Portex 101/870/080CZ
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55 reports

All Tube, tracheostomy (w/wo connector) 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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