MODULITHRecalls & reported problems across all models

We found 2 models of MODULITH by Storz Medical AG in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2019 and Sep 30, 2026 — classified as 2 deaths, 30 injuries.

The most frequently reported specific device problem is “Misfocusing” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported MODULITH problems

MODULITH models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MODULITH® SLX-F2

  Lithotriptor, Extracorporeal Shock-Wave,Urological
  17 reports
• MODULITH® SLX-F2

  Lithotriptor, Extracorporeal Shock-Wave,Urological
  2 deaths15 reports

Recent MODULITH adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Minor symptomatic hematoma was reported by the patient to the hospital on (b)(6) 2026 following ESWL treatment (b)(6) 2026. The patient was admitted to the hospital for observation. Patient was haemodynamically stable. The patient was discharged from the hospital on (b)(6) 2026. No comorbidities or concomitant medications that could increase the risk of bleeding were reported.

  Patient problems: Hematoma

  MAUDE report 50945097 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  POST ESWL TREATMENT, PATIENT COMPLAINED OF PAIN.

  Patient problems: Hematoma

  MAUDE report 24389224 ↗
• InjuryNov 6, 2025Misfocusing; Use of Device Problem; Misfocusing; Use of Device Problem

  POST ESWL TREATMENT, CT SCAN CONFIRMED LARGE SUBCAPSULAR HEMATOMA, NO ACTIVE BLEED. ADMITTED WITH PAIN, BLOOD PRESSURE DROP, NO ACTIVE BLEED, NO TRANSFUSION.

  Patient problems: Hematoma

  MAUDE report 23486491 ↗
• InjuryNov 6, 2025Misfocusing; Use of Device Problem; Misfocusing; Use of Device Problem

  ON (B)(6) 2025 CTU POST ESWL TREATMENT CONFIRMED LARGE SUBCAPSULAR HEMATOMA. ADMITTED ON (B)(6) 2025 FOR OBSERVATION, NO TRANSFUSION OR OTHER INTERVENTION, DISCHARGED ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 23486490 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONFIRMED HEMATOMA POST ESWL TREATMENT. TREATING PHYSICIAN INITIALLY REPORTED PATIENT HAD MULTIPLE EMBOLIZATIONS AND EVENTUALLY WENT ON TO REQUIRE A NEPHRECTOMY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING DATE OF EVENT, ADDITIONAL MEDICAL TREATMENT, PROGNOSIS. HEMATOMA ARE A KNOWN SIDE EFFECT OF ESWL TREATMENT.

  Patient problems: Hematoma

  MAUDE report 22545247 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONFIRMED HEMATOMA POST ESWL TREATMENT, SEVERITY UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING DATE OF EVENT, MEDICAL TREATMENT OR PROGNOSIS. HEMATOMA ARE A KNOWN SIDE EFFECT OF ESWL TREATMENT.

  Patient problems: Hematoma

  MAUDE report 22545236 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONFIRMED HEMATOMA POST ESWL TREATMENT, SEVERITY UNKNOWN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING DATE OF THE EVENT, MEDICAL TREATMENT OR PROGNOSIS. HEMATOMA ARE A KNOWN SIDE EFFECT OF ESWL TREATMENT.

  Patient problems: Hematoma

  MAUDE report 22545230 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROVIDER REPORTED A HEMATOMA OCCURRED AROUND A YEAR AGO POST ESWL. THE PATIENT INVOLVED THEN CONSULTED ANOTHER MEDICAL DOCTOR WHO ADVISED THAT THE KIDNEY SHOULD BE REMOVED. MANUFACTURER IS UNABLE TO CONFIRM THAT THE PATIENT HAS RECEIVED A NEPHRECTOMY. REPEATED ATTEMPTS TO COLLECT MORE INFORMATION HAVE BEEN UNSUCCESSFUL. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 4/25/2025.

  Patient problems: Hematoma

  MAUDE report 22071945 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RENAL HEMATOMA, MEETING THE CRITERIA FOR BEING SERIOUS, OCCURRED AFTER ESWL TREATMENT ON (B)(6) 2025. THE PATIENT WAS SYMPTOMATIC AND ATTENDED A&E THE DAY AFTER ESWL WITH FLANK PAIN. CT WAS PERFORMED WHICH SHOWED THE HEMATOMA. PATIENT WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS AND WAS GIVEN IV FLUIDS AND IV ANTIBIOTICS. PATIENT WAS MONITORED BUT REMAINED CLINICALLY STABLE. AT DISCHARGE THE PATIENT WAS GIVEN ANTIBIOTICS AND WAS ASKED TO RETURN 2 TIMES POST TREATMENT FOR BLOOD TESTS BUT WAS NOT READMITTED. PATIENT HAS BEEN ASKED TO FOLLOW UP THE END OF (B)(6).

  Patient problems: Hematoma

  MAUDE report 22064438 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBCAPSULAR HEMATOMA 43MM WITHOUT BLEEDING POST EXTRA CORPOREAL SHOCK WAVE TREATMENT.

  Patient problems: Hematoma

  MAUDE report 19574332 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBCAPSULAR HEMATOMA 35MM WITHOUT ACTIVE BLEEDING POST EXTRACORPOREAL SHOCK WAVE TREATMENT.

  Patient problems: Hematoma

  MAUDE report 19574252 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OEM STORZ MEDICAL WAS INFORMED BY MEDICAL PERSONNEL FROM TREATING HOSPITAL THAT A PATIENT WAS DIAGNOSED WITH HEMATOMA POST ESWL TREATMENT AND A NEPHRECTOMY WAS PERFORMED. NO INFORMATION CONCERNING THE PATIENT OR THEIR PRE AND POST ESWL CONDITION HAS BEEN FORTHCOMING FROM THE TREATING PHYSICIAN OR FACILITY. THE DEVICE HAS BEEN EVALUATED AND NO ISSUES WERE DETECTED. 11/28/22 ADDITIONAL INFORMATION RECEIVED: ESWL TREATMENT ON (B)(6) 2022, LEFT VESICOURETERIC JUNCTION, 1 STONE 5MM, AT ENERGY LEVELS 1.0 - 5.0 FOR A TOTAL OF 3000 SHOCKS. PATIENT ADMITTED (B)(6) 2022 FOR COMPLAINT OF LOIN PAIN. CT PERFORMED (B)(6) 2022 SHOWS LRFT PERINEPHRIC HEMATOMA.

  Patient problems: Hematoma; Unspecified Kidney or Urinary Problem

  MAUDE report 16857340 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OEM STORZ MEDICAL AG WAS INFORMED BY MEDICAL PERSONNEL FROM TREATING HOSPITAL THAT A PATIENT WAS DIAGNOSED WITH HEMATOMA POST ESWL TREATMENT. PATIENT ADMITTED FOR LEFT RENAL STONE TREATMENT WAS COMPLICATED BY LEFT ACUTE SUBCAPSULAR PERI-RENAL HEMATOMA WITH MASS EFFECT (IN POST OPERATIVE PERIOD).

  Patient problems: Hematoma

  MAUDE report 16857064 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OEM STORZ MEDICAL AG WAS INFORMED BY MEDICAL PERSONNEL FROM (B)(6) HOSPITAL THAT A PATIENT WAS DIAGNOSED WITH HEMATOMA POST ESWL TREATMENT. THE FACILITY AND PHYSICIAN HAS PROVIDED LIMITED INFORMATION CONCERNING THE PATIENT PRE AND POST ESWL TREATMENT. HEMATOMA SIZE WAS BETWEEN 2.2 AND 3CM. PATIENT DID NOT REQUIRE TRANSFUSION BUT WAS ADMITTED FOR STRICT MONITORING. THE DEVICE HAS BEEN EVALUATED AND NO ISSUES WERE DETECTED.

  Patient problems: Hematoma

  MAUDE report 16856573 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OEM STORZ MEDICAL WAS INFORMED BY MEDICAL PERSONNEL FROM TREATING HOSPITAL THAT A PATIENT WAS DIAGNOSED WITH HEMATOMA POST ESWL TREATMENT. NO INFORMATION CONCERNING THE PATIENT OR THEIR PRE AND POST ESWL CONDITION HAS BEEN FORTHCOMING FROM THE TREATING PHYSICIAN OR FACILITY. THE DEVICE HAS BEEN EVALUATED AND NO ISSUES WERE DETECTED. (B)(6) 2022 ADDITIONAL INFORMATION RECEIVED: ESWL TREATMENT (B)(6) 2022, RIGHT KIDNEY STONE 5MM AT ENERGY LEVEL 1.0 - 5.0 FOR TOTAL OF 3000 SHOCKS. PATIENT TREATED FOR SEVERE RIGHT LOIN PAIN, ADMITTED TO WARD AND CT SHOWS RIGHT PERINEPHRIC HEMATOMA WITH ACTIVE CONTRAST EXTRAVASATION UP TO 4.8CM. BLOOD PRESSURE BORDERLINE, HB DROPPED FROM 13.5 TO 9.3.

  Patient problems: Hematoma

  MAUDE report 16856558 ↗