PIEZOWAVE2 100505Recalls & reported problems
Richard Wolf GmbH · PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) and for the acoustic compression therapy (ACT), U: 100-127/220-240VAC, 50/60Hz, Dim. (wxhxd): 405x226x450mm · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207008454), received between Jan 30, 2025 and Nov 24, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Stroke/CVA1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PIEZOWAVE 2 WAS USED ON A PATIENT FOR MYOFASCIAL ACOUSTIC COMPRESSION THERAPY (MYACT) ON THE LEFT LEG IN A MEDICAL FACILITY. THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH AN ACUTE MENISCUS ROOT TEAR IN HER LEFT KNEE, CONFIRMED BY IMAGING, AS WELL AS PERSISTENT NEUROPATHIC SYMPTOMS; HOWEVER, BASED ON THE CURRENT CLINICAL ASSESSMENT AND AVAILABLE FINDINGS, A DIRECT CAUSAL LINK TO THE MYACT TREATMENT IS CONSIDERED UNLIKELY AND CANNOT BE CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633150 ↗InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RICHARD WOLF WAS INFORMED THAT A PATIENT EXPERIENCED A STROKE AFTER MANUAL CHIROPRACTIC MANIPULATION. PRIOR TO THE MANUAL CHIROPRACTIC TREATMENT, THE PIEZOWAVE WAS USED FOR MYOFASCIAL ACOUSTIC COMPRESSION MASSAGE. THERE IS NO INFORMATION AVAILABLE FROM THE CHIROPRACTOR ON THE SPECIFIC PIEZOWAVE CONTROL UNIT OR THERAPY SOURCE THAT WERE UTILIZED DURING THE TREATMENT. THE CHIROPRACTOR CONTINUES TO USE THE PIEZOWAVE UNITS AND THERAPY SOURCES FOR MYOFASCIAL ACOUSTIC COMPRESSION MASSAGE TREATMENT.
Patient problems: Stroke/CVA
MAUDE report 22442734 ↗InjuryJan 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
RICHARD WOLF GMBH BECAME AWARE OF A PATIENT ALLEGATION OF POTENTIAL INJURY VIA A LAWSUIT FILED IN THE USA. NO FURTHER DETAILS WERE PROVIDED IN THE LAWSUIT.
Patient problems: Insufficient Information
MAUDE report 21277398 ↗
Other Massager, therapeutic, electric devices
- Theragun Theragun PROTherabody, Inc. · Massager, Therapeutic, Electric1 recall51 reports
- Thermage TG-2BSolta Medical · Massager, Therapeutic, Electric1 recall0 reports
- PIEZOWAVE2 100506USRichard Wolf GmbH · Massager, therapeutic, electric1 recall0 reports
- Thermage TTNS3.00E4-1200Solta Medical · Massager, Therapeutic, Electric30 reports
- THERMAGE FLX TT4.00F6-900Solta Medical · Massager, Therapeutic, Electric27 reports
- THERMAGE FLX TT0.25F6-450Solta Medical · Massager, Therapeutic, Electric13 reports
- Thermage TTNS3.00E4-900Solta Medical · Massager, Therapeutic, Electric9 reports
- THERMAGE FLX TT4.00F6-600Solta Medical · Massager, Therapeutic, Electric8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.