MODULITH® SLX-F2 (REF 29000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630039100919), received between Oct 20, 2021 and Sep 30, 2026 — classified as 17 injuries.

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 17 most recent of 17 reports, 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 ↗
• 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 ↗
• 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. 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 16855163 ↗
• 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. 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 16855162 ↗
• 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. THE FACILITY AND PHYSICIAN HAS PROVIDED LIMITED INFORMATION CONCERNING THE PATIENT PRE AND POST ESWL TREATMENT. PATIENT WAS ADMITTED FOR TREATMENT ON (B)(6) 2023 FOR LEFT RENAL STONE WHICH WAS COMPLICATED BY 7X5X9CM PERINEPHRIC HEMATOMA WITH HAEMORRHAGIC SHOCK.

  Patient problems: Hematoma

  MAUDE report 16855161 ↗
• 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. 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 16855160 ↗
• 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. 11/28/22 ADDITIONAL INFORMATION RECEIVED: ESWL TREATMENT ON (B)(6) 2022 LEFT MIDDLE CALYX STONE 13MM X 3MM AT ENERGY LEVEL 1.0 - 6.0 FOR TOTAL OF 3000 SHOCKS. PATIENT UNDERWENT CT ON (B)(6) 2022 AND DIAGNOSED WITH LEFT PERINEPHRIC HEMATOMA (18CM X 10CM) WITH ACTIVE BLEEDING AT LOWER POLE OF KIDNEY. PERSISTENT TACHYCARDIA AND PAIN WITH HB DROP.

  Patient problems: Hematoma

  MAUDE report 16855154 ↗
• 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. ON (B)(6) 2022 ADDITIONAL INFORMATION RECEIVED: ESWL TREATMENT ON (B)(6) 2022 TO 14MM RIGHT RENAL STONE AT ENERGY LEVEL 1.0 - 6.0 FOR A TOTAL OF 3000 SHOCKS. PATIENT COMPLAINED OF LOIN PAIN AND HYPOTENSION AND HB DROPPED. CT OF ABDOMEN AND PELVIS WITH CONTRAST DONE ON (B)(6) 2022 SHOWS RIGHT ACUTE PERINEPHRIC HEMATOMA WITH ACUTE BLOOD SEEN EXTENDING TO RIGHT PARACOLIC GUTTER AND DOWN TO PELVIS. A 7MM ARTERIAL ENHANCING FOCUS IS NOTED AT POSTERIOR ASPECT OF UPPER POLE OF RIGHT KIDNEY, WHICH PERSISTS ON PORTOVENOUS PHASE AND SHOWED SIGNIFICANT CHANGE OF SIZE OR SHAPE. A FEW TINY ARTERIALLY ENHANCING FOCI AT POSTERIOR ASPECT WITHOUT DEFINITE POOLING SEEN ON PORTOVENOUS PHASES. ACTIVE CONTRAST ESTRAVASATION CANNOT BE EXCLUDED. RIGHT RENAL EMBOLIZATION PERFORMED ON (B)(6) 20/22.

  Patient problems: Hematoma; Unspecified Kidney or Urinary Problem

  MAUDE report 16855150 ↗
• InjuryOct 20, 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 12668553 ↗