Dornier MedTech Delta IIIRecalls & reported problems
Dornier MedTech GmbH · Delta III Lithotripter, 15 KW · Class 2
Quick summary
This Dornier MedTech Delta III machine uses shock waves to break up kidney stones. The 27 reports describe patients developing bruising and blood collections (hematomas) after the procedure, plus two reports of a ruptured spleen. All 27 reports describe injuries, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04049957005429), received between Apr 26, 2023 and Aug 13, 2026 — classified as 26 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
Patient problems
- Hematoma25
- Rupture1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
Patient Splenic Rupture was reported to have occured following a procedure utilizing a Dornier Delta III SN: (b)(6).
Patient problems: Rupture
MAUDE report 50241365 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2026-00011 ON (B)(6) 2026.
Patient problems: Hematoma
MAUDE report 24994974 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A DORNIER DELTA III SN: (B)(6).
Patient problems: Hematoma
MAUDE report 24984422 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00044 ON (B)(6) 2026.
Patient problems: Hematoma
MAUDE report 24066334 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A DORNIER DELTA III SN: (B)(6).
Patient problems: Hematoma
MAUDE report 24056020 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00036 ON 10/14/2025.
Patient problems: Hematoma
MAUDE report 23299308 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A DORNIER DELTA III SN: (B)(6).
Patient problems: Hematoma
MAUDE report 23293463 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00033 ON 08/22/2025.
Patient problems: Hematoma
MAUDE report 22931868 ↗InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A DORNIER DELTA III SN: (B)(6).
Patient problems: Hematoma
MAUDE report 22876594 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00029 ON (B)(6) 2025.
Patient problems: Hematoma
MAUDE report 22539802 ↗InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00024 ON (B)(6) 2025.
Patient problems: Hematoma
MAUDE report 22343304 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2025-00014 ON 04/22/2025.
Patient problems: Hematoma
MAUDE report 21890101 ↗InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2024-00006 ON (B)(6) 2024.
Patient problems: Hematoma
MAUDE report 19071144 ↗InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER (B)(4) ON 01/31/2024.
Patient problems: Hematoma
MAUDE report 18667677 ↗InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00051 ON 12/12/2023.
Patient problems: Hematoma
MAUDE report 18324113 ↗InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00048 ON 12/12/2023.
Patient problems: Hematoma
MAUDE report 18324090 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00040 ON (B)(6) 2023.
Patient problems: Hematoma
MAUDE report 17972988 ↗InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER (B)(4) ON (B)(6) 2023.
Patient problems: Hematoma
MAUDE report 17972773 ↗InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00038 ON 09/29/2023.
Patient problems: Hematoma
MAUDE report 17874557 ↗InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00027 ON 08/10/2023.
Patient problems: Hematoma
MAUDE report 17569943 ↗InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00023 ON (B)(6) 2023.
Patient problems: Hematoma
MAUDE report 17296351 ↗InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00020 ON 06/20/2023.
Patient problems: Hematoma
MAUDE report 17189422 ↗InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00021 ON 06/20/2023.
Patient problems: Hematoma
MAUDE report 17189415 ↗InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00019 ON (B)(6) 2023
Patient problems: Hematoma
MAUDE report 17189414 ↗InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2023-00015 ON (B)(6) 2023
Patient problems: Hematoma
MAUDE report 17048987 ↗
Other Lithotriptor, Extracorporeal Shock-Wave,Urological devices
- Dornier MedTech Compact SigmaDornier MedTech GmbH · Lithotriptor, Extracorporeal Shock-Wave,Urological17 reports
- MODULITH® SLX-F2Storz Medical AG · Lithotriptor, Extracorporeal Shock-Wave,Urological17 reports
- MODULITH® SLX-F2Storz Medical AG · Lithotriptor, Extracorporeal Shock-Wave,Urological2 deaths15 reports
- Modularis Variostar 01157200Siemens Healthcare GmbH · Lithotriptor, extracorporeal shock-wave,urological1 report
- PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE P3000002United Service Solutions, LLC · Lithotriptor, Extracorporeal Shock-Wave, Urological1 death1 report
- Dornier Delta III K1045938Dornier MedTech GmbH · Lithotriptor, Extracorporeal Shock-Wave, Urological1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.