SmartVest SQL_RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B102090488S0110), received between Jan 23, 2023 and Apr 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A USER COMPLAINT ALLEGING THE DEVICE OVERHEATED, CAUSING THE TUBING AND METAL COUPLING TO BECOME HOT AND RESULTING IN A BLISTER ON THE USER'S ABDOMEN.

  Patient problems: Blister

  MAUDE report 21869620 ↗
• MalfunctionJan 23, 2023Overheating of Device; Overheating of Device

  THE MANUFACTURER RECEIVED A COMPLAINT FROM A USER STATING RECENTLY THE MACHINE IS HEATING UP AND IT IS BURNING HOT WHEN SHE TURNS IT ON. SHE SAID IT WOULD BURN HER HAND IF SHE LEFT HER HAND THERE. THE MACHINE WOULD THEN JUST POWER OFF. THERE WAS NO REPORTED INJURY. MANUFACTURERS EVALUATION SUMMARY: THE DEVICE WAS RETURNED ON (B)(6) 2022. ENGINEERING EVALUATED THE RETURNED DEVICE AND FOUND NO ANOMALIES WITH THE DEVICE ON INITIAL REVIEW. THE DEVICE WAS THEN SUBMITTED FOR PERFORMANCE TESTING TO FINAL TEST SPECIFICATIONS AND PASSED ALL TESTING. THE DEVICE WAS OPERATED UNDER NORMAL OPERATING CONDITIONS USING PATIENTS DEVICE SETTINGS, THE OUTSIDE SURFACE TEMPERATURE OF THE DEVICE WAS MEASURED, A TEMPERATURE OF 96.7 DEGREES F WAS RECORDED. WE WERE UNABLE TO DUPLICATE THE COMPLAINT OF DEVICE HEATING UP AND SHUTTING OFF. THE INVESTIGATION WAS CLOSED ON 11/18/2022.

  Patient problems: Burn(s)

  MAUDE report 16225135 ↗