Modularis Variostar 01157200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869008974), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K070799); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem

  MANUFACTURER BECAME AWARE OF AN EVENT FOLLOWING A PROCEDURE ON THE MODULARIS VARIOSTAR UNIT. THE EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) PROCEDURE WAS PERFORMED ON A STONE IN THE LEFT KIDNEY. THE PROCEDURE WAS PERFORMED AT 4000 SHOCKWAVES AND 189 JOULES IN TOTAL; AVERAGE ENERGY LEVEL USED WAS AT 3.7. FOLLOWING THE PROCEDURE THE TREATED KIDNEY STONE LOOKED DISINTEGRATED ON AN X-RAY IMAGE. THE PHYSICIAN COMMUNICATED THAT THE PATIENT WAS BLEEDING FROM THE LEFT URETER. A SMALL BLISTER AT THE SHOCKWAVE SKIN ENTRANCE WAS REPORTED AS WELL, HOWEVER, ACCORDING TO THE PHYSICIAN THIS NOTHING WAS OUT OF THE ORDINARY. LATER IT WAS NOTICED THAT THE PATIENT'S SPLEEN WAS BLEEDING. THE SPLEEN WAS SURGICALLY REMOVED. THE DOCTOR INDICATED IT WAS A RARE COMPLICATION OF SUCH PROCEDURE AND WAS NOT ASSIGNING CAUSALITY TO THE EQUIPMENT ITSELF. NO FAILURE OR ERROR OF THE UROLOGICAL DEVICE WAS REPORTED. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: Hematoma

  MAUDE report 13904969 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070799. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2016 · Sep 24, 2015 · Terminated
  MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis.