Parker Flex-Tip H-PFTVVC-80Recalls & reported problems

Salter Labs · Parker Trach Vac with Flex-Tip and PVC Cuff (H-PFTVVC), 8.0mm · Class 2

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10749065191809), received between Feb 28, 2024 and Apr 29, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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

Difficult to Remove1
Material Fragmentation1
Material Integrity Problem1
Unintended Deflation1

Patient problems

Insufficient Information2
Low Oxygen Saturation1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 29, 2026Material Fragmentation
IT WAS REPORTED THAT DURING USE, THE INFLATION TUBE BROKE WITHOUT BECOMING DISLODGED. THE PATIENT WAS EXTUBATED, AND REINTUBATION WAS NOT PERFORMED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Low Oxygen Saturation
MAUDE report 25038275 ↗
InjuryAug 1, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED, DUE TO CARBON DIOXIDE (CO2) NARCOSIS, THE DOCTOR TRIED TO INTUBATE THE PATIENT, BUT THE SEDATION DID NOT WORK WELL AND THE PATIENT HAD A LOT OF BODY MOVEMENTS, A BITE BLOCK WAS USED; THE INFLATING TUBE WAS DISCONNECTED AND THE PATIENT WAS REINTUBATED. THE ANESTHESIOLOGIST SPECULATED THE TUBE DISCONNECTION MAY HAVE BEEN CAUSED BY THE BITE BLOCK OR THE PATIENT'S TEETH INTERFERING WITH THE TUBE. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22691131 ↗
MalfunctionJul 16, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED: AFTER MORE THAN 24 HOURS OF PLACEMENT, THE MEDICAL STAFF FOUND IT HARD TO REMOVE THE TRACHEAL TUBE BECAUSE THE AIR IN THE CUFF COULD NOT BE REMOVED AND IT FELT AS IF IT WAS STICKING TO THE TRACHEAL WALL DURING EXTUBATING. THERE WAS NO REPORTED INJURY OR ADDITIONAL MEDICAL INTERVENTION.
Patient problems: Insufficient Information
MAUDE report 22527381 ↗
MalfunctionFeb 28, 2024Unintended Deflation; Unintended Deflation
THE INFLATING CUFF DISCONNECTED FROM THE TRACHEAL TUBE. THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH A DIFFERENT TRACHAEL TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18804831 ↗

Device details

UDI-DI	`10749065191809`
Brand	Parker Flex-Tip
Model	H-PFTVVC-80
Company	Salter Labs
Product code	BTR · Tube, Tracheal (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	Jun 19, 2019

Device type (GMDN): Cuff-suction endotracheal tube

A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

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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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