BioStim SDRecalls & reported problems
Biomedical Life Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857771003088), received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem
OUR CUSTOMER, (B)(6) FROM (B)(6) MEDICAL EMAILED IN JANUARY 2019 US THAT ONE OF HER CUSTOMERS, (B)(6), HAD USED BIOSTIM SD TENS UNIT AND PLACED THE ELECTRODES ON HER BUTTOCKS. THE EXACT DATE WAS NOT SUPPLIED. SHE SAID IT WAS PROBABLY (B)(6) 2018. PATIENT COMPLAINED THAT SHE ENCOUNTERED BURNS WITHIN 5 MINUTES OF USING THE DEVICE. THE USER TOLD (B)(6) ABOUT IT WHO CONTACTED BIOMEDICAL LIFE SYSTEMS (BMLS) AND SENT IN THE PHOTO. WE ASKED (B)(6) TO OBTAIN INFORMATION FROM (B)(6) WITH DETAILS OF THE INCIDENT. SHE DECLINED. BMLS CONTACTED (B)(6) TO OBTAIN DETAILS OF THE EVENT.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 9836506 ↗
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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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