Amvex Vacuum Regulator PIDRecalls & reported problems

Ohio Medical, LLC · VR-PI series, VacReg, Ped Int 3Mode 160mmHg, Digital · Class 2

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 00628101501389), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unclear Information” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Unclear Information1

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.

MalfunctionFeb 18, 2025Unclear Information; Unclear Information
USER FACILITY CONTACTED OHIO MEDICAL ON (B)(6) 2024 TO EXPLAIN THAT LABEL ON TOP OF DEVICE DID NOT ALIGN WITH LABEL ON FRONT OF DEVICE (LABEL IDENTIFIES MODE SELECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21399355 ↗

Device details

UDI-DI	`00628101501389`
Brand	Amvex Vacuum Regulator
Model	PID
Company	Ohio Medical, LLC
Product code	KDP · Regulator, Vacuum
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Aug 23, 2018

Device type (GMDN): Vacuum suction regulator/regulation set, general-purpose

A noninvasive device/collection of noninvasive devices designed to connect to the terminal unit (wall outlet) of a vacuum pipeline system to control the degree of negative pressure during the evacuation of fluids, mucus, or solids during a range of clinical applications (e.g., not dedicated to thoracic suction). It allows continuous and/or intermittent suction at variable levels, incorporates a manometer and controls for monitoring/adjusting the level of suction, and may include collection containers, tubing or a stand/mount; it does not include patient contact devices (e.g., handpiece/tip, catheter).

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All Regulator, Vacuum devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.