StimLabRecalls & reported problems

Micropace Pty Limited · Diagnostic cardiac computerized reconfigurable stimulator system · 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 09349714004630), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pacing Problem” (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

Pacing Problem1

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 2, 2025Pacing Problem; Pacing Problem
IT WAS REPORTED THAT DURING PULSE FIELD ABLATION (PFA) PROCEDURE USING A MICROPACE STIMULATOR PACING BECOMES UNAVAILABLE AFTER ENERGIZATION. DURING THE PROCEDURE THERE IS AN ISSUE WITH THE MICRO PACE AND STIMULATION CAPABILITIES BECOME UNAVAILABLE DURING THE PROCEDURE, THERE WAS NO BACK UP PACING IN PLACE FOR EMERGENCY SITUATIONS. NO PROCEDURE IN PROGRESS HAS BEEN CANCELLED AND THERE HAVE BEEN NO PATIENT COMPLICATIONS. IT IS NOT KNOWN IF THE SYSTEM WILL BE RETURNED FOR ANALYSIS AS IT IS TO BE SERVICED ON SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21053590 ↗

Device details

UDI-DI	`09349714004630`
Brand	StimLab
Model	StimLab
Catalog no.	MP3172
Company	Micropace Pty Limited
Product code	JOQ · Generator, Pulse, Pacemaker, External Programmable
Class	Class 2
FDA submission	K072200
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 21, 2026

Device type (GMDN): Cardiac electrophysiology stimulation system

An assembly of devices programmed to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It typically includes electrodes/leads applied to the heart and an external pulse generator (EPG). It may be used in asynchronous or synchronous mode, to deliver stimuli of variable strength, and for pacing in a wide range of cycle lengths (typically from 150 to 1500 ms). It is used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and to assess sinus node function.

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All Generator, Pulse, Pacemaker, External Programmable devices →

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