AccelStim UBHS-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08050040997213), received between Jun 5, 2023 and Jul 22, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem 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.

Most reported problems

Recent adverse event reports

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

• InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT CLAIMED THE DEVICE RAISED HER BLOOD PRESSURE CAUSED HER TO GO TO THE EMERGENCY ROOM. ON (B)(6) 2025, A CALL WAS MADE TO THE PATIENT TO GAIN ADDITIONAL INFORMATION. PATIENT DECLINED TO PROVIDE ADDITIONAL DETAILS REGARDING HER EXPERIENCE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 22569918 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED AND REPORTED THAT SHE TRIED A DIFFERENT TYPE OF GEL, WHICH SHE USED A MINERAL OIL/BABY OIL AND THE UNIT HAS BURNED HER FOR THE SECOND TIME. PATIENT WAS UNABLE TO PROVIDE PICTURES AND STATED THAT THE BURN HAS HEALED.

  Patient problems: Burn(s)

  MAUDE report 21678918 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION PROVIDED STATES THAT PATIENT WAS PRESCRIBED ACCELSTIM DEVICE (B)(6) 2022. PT SAID SHE USED DEVICE FOR 5 MONTHS WITH NO ISSUES. SHE STATED THAT SHE HAS GOTTEN BURNED TWICE, ONCE 5 WEEKS PRIOR TO CALLING CUSTOMER SERVICE AND AGAIN 3 WEEKS LATER. PT DISCONTINUED USE OF THE DEVICE. THE DEVICE WAS REPLACED WITH A NEW UNIT.

  Patient problems: Burn(s)

  MAUDE report 17066044 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION PROVIDED STATES THAT PATIENT WAS PRESCRIBED ACCELSTIM DEVICE (B)(6) 2022. PT SAID SHE ONLY USED IT 3-4 TIMES. AFTER LAST TREATMENT RED BURNS APPEARED ABOUT THE SIZE OF THE DEVICE ON HER FOOT, 2-3 BURNS ON THE BACK BOTTOM OF HER FOOT WHERE THE DEVICE WAS AND ON THE TOP OF THE FOOT. SHE STOPPED USING THE DEVICE. PATIENT SAID THE BURNS HAVE SINCE HEALED . PT STATED SHE TRIED ALTERNATIVE MINERAL OIL AND GLYCERIN WITH THE SAME RESULTS.

  Patient problems: Burn(s)

  MAUDE report 17059858 ↗