MODULITH® SLX-F2 (UDI 07630039100230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630039100230), received between Apr 15, 2019 and Nov 6, 2025 — classified as 2 deaths, 13 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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH A HEMATOMA FOLLOWING ESWL TREATMENT ON (B)(6) 2022. PATIENT WAS ADMITTED TO THE HOSPITAL BUT ADDITIONAL INFORMATION CONCERNING ADMISSION AND DISCHARGE HAVE NOT BEEN PROVIDED BY THE PHYSICIAN.

  Patient problems: Hematoma

  MAUDE report 16855149 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT WAS DIAGNOSED WITH A RUPTURED KIDNEY FOLLOWING ESWL TREATMENT ON (B)(6) 2021 AND WAS ADMITTED TO THE HOSPITAL LATER THAT DAY. PATIENT WAS GIVEN 1 UNIT OF BLOOD IN THE ER AND HAS SUBSEQUENTLY BEEN GIVEN 2 MORE IN ICU. HEMOGLOBIN IS NOW STABLE AT 7 FOR OVER 24 HRS AND HAS BEEN DISCHARGED FROM ICU, BUT REMAINS HOSPITALIZED FOR FURTHER EVALUATION. PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hematoma; Rupture

  MAUDE report 11682500 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH A HEMATOMA FOLLOWING ESWL TREATMENT ON (B)(6) 2021. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 AND WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2021.

  Patient problems: Hematoma

  MAUDE report 11565737 ↗
• DeathJan 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE LEARNED THAT A PATIENT PASSED AWAY DURING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE AT (B)(6) HOSPITAL ADA, IN ADA, (B)(6) ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11227277 ↗
• DeathNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, FOLLOWING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE AT (B)(6) SVC. IN (B)(6) ON (B)(6) 2019, THE PATIENT REPORTED TO THE HOSPITAL THAT EVENING. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE. THE PATIENT WAS TRANSFUSED WITH 7 UNITS OF BLOOD AND GIVEN VASOPRESSORS. ANOTHER 8 UNITS OF BLOOD WERE TRANSFUSED. CAT SCAN REVEALED VERY LARGE INTRA- AND RETROPERITONEAL HEMATOMA OF THE RIGHT KIDNEY. WITHIN AN UNDISCLOSED TIME FRAME THE PATIENT WENT INTO RENAL FAILURE AND WAS PLACED ON DIALYSIS. SOON TO FOLLOW THE PATIENT DEVELOPED DIFFERENTIAL INTRAVASCULAR COAGULOPATHY AND THE FAMILY MADE THE DECISION TO TERMINATE HIS VITAL FUNCTIONS ON SUNDAY, (B)(6) 2019. THE PATIENT HAD A MEDICAL HISTORY THAT CONSISTED OF MORBID OBESITY (5'8" TALL (B)(6) LBS), HYPERTENSION, CIRRHOSIS, A PLATELET COUNT OF 58,000, AND A HEART VALVE REPLACEMENT.

  Patient problems: Death; Hematoma

  MAUDE report 9345162 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT PRESENTED WITH A RENAL HEMATOMA FOLLOWING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE AND WAS HOSPITALIZED. WE HAVE NOT BEEN ABLE TO OBTAIN ANY FURTHER DETAILS ABOUT THIS EVENT OR PATIENT CONDITION.

  Patient problems: Hematoma

  MAUDE report 9163309 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT PRESENTED WITH A HEMATOMA FOLLOWING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE ON (B)(6) 2019. THE PATIENT WAS ADMITTED THAT DAY AND WAS TRANSFUSED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

  Patient problems: Hematoma

  MAUDE report 8962893 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT PRESENTED WITH A HEMATOMA FOLLOWING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE ON (B)(6) 2019. THE PATIENT WAS ADMITTED THAT DAY AND WAS TRANSFUSED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

  Patient problems: Hematoma

  MAUDE report 8962891 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT PRESENTED WITH A HEMATOMA FOLLOWING AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE. THE ONLY PATIENT INFORMATION PROVIDED WAS THAT PATIENT WAS ELDERLY AND FRAIL AND THE POST-OP SYMPTOMS WERE NOT SEVERE. WE HAVE NOT BEEN ABLE TO OBTAIN ANY FURTHER DETAILS ABOUT THIS EVENT OR PATIENT CONDITION.

  Patient problems: Hematoma

  MAUDE report 8612131 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, THE PATIENT PRESENTED WITH A RECTO-PERITONEAL BLEED THE DAY AFTER A LEFT EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY PROCEDURE. THE PATIENT WAS ADMITTED AND WAS HOSPITALIZED FOR 8 DAYS. WE HAVE NOT BEEN ABLE TO OBTAIN ANY FURTHER DETAILS ABOUT THIS EVENT OR PATIENT CONDITION.

  Patient problems: Hematoma

  MAUDE report 8515172 ↗