Softwave Gold Li OW100S-USRecalls & reported problems
MTS Medical AG · The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. OW100S-US is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S-US is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S-US is indicated for use in conjunction with standard of care burn treatment(s) · Class 2
Data updated Oct 18, 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 04260484571267), received between Jul 30, 2026 and Jul 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Inappropriate/Inadequate Shock/Stimulation1
- Patient Device Interaction Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Burning Sensation1
- Neuropathy1
- Pain1
- Pelvic Pain1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem
ON (B)(6) 2026, I UNDERWENT SOFTWAVE EXTRACORPOREAL SHOCKWAVE THERAPY APPLIED OVER THE SACRALREGION AT STRETCH AFFECT. PRIOR TO TREATMENT, I DISCLOSED IN WRITING AND VERBALLY A COMPLEX SPINAL ANDNEUROLOGIC HISTORY INCLUDING: COMPLETE L5-S1 DISC FAILURE EFFACING THE DORSAL ROOT GANGLION WITHCHEMICAL RADICULITIS; DURAL ECTASIA SECONDARY TO CONNECTIVE TISSUE DISEASE; TARLOV (PERINEURAL) CYSTSINCLUDING AN S3 CYST; SACRAL ALLODYNIA WITH PELVIC NERVE INVOLVEMENT; PRIOR TO TREATMENT, MY SYMPTOMSWERE STABLE, PREDICTABLE, AND PRIMARILY POSITIONAL/PRESSURE DEPENDENT, WITH MINIMAL TO NO PAIN ATREST. FOLLOWING THE (B)(6) 2026 TREATMENT, I EXPERIENCED A SIGNIFICANT AND PERSISTENT DETERIORATION FROMBASELINE INCLUDING: SEVERE NEUROPATHIC PAIN, EXPANDED SACRAL AND PELVIC NERVE DISTRIBUTION, NEWBURNING NEUROPATHIC PAIN AT REST, PAINFUL NERVE PULSES RADIATING INTO HIGHLY SENSITIVE PRIVATE/PELVICREGIONS NOT PREVIOUSLY INVOLVED, NEW BURNING SENSATIONS IN THE LEGS, INCLUDING CUTTING SENSATIONS,TWITCHING, AND PAINFUL NERVE PULSES, PROGRESSIVE PRESSURE INTOLERANCE AFFECTING SITTING, LYING DOWN,AND WALKING, PERSISTENT BUZZING SENSATIONS ALONG NEW NERVE PATHWAYS AND A SIGNIFICANT DETERIORATIONIN MY FUNCTIO
Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Neuropathy; Pain; Pelvic Pain; Undesired Nerve Stimulation
MAUDE report 50084120 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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