Dornier MedTech Compact SigmaRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04049957000011), received between Apr 26, 2023 and Jun 9, 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.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2026-00019 ON (B)(6) 2026.

  Patient problems: Hematoma

  MAUDE report 25442178 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2026-00018 ON (B)(6) 2026.

  Patient problems: Hematoma

  MAUDE report 25439478 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A COMPACT SIGMA SN (B)(6).

  Patient problems: Hematoma

  MAUDE report 25355401 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A COMPACT SIGMA SN (B)(6).

  Patient problems: Hematoma

  MAUDE report 25355379 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED AND INITIALLY REPORTED TO FDA UNDER 1037955-2026-00007 ON (B)(6) 2026.

  Patient problems: Hematoma

  MAUDE report 24577752 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HEMATOMA WAS REPORTED TO HAVE OCCURED FOLLOWING A PROCEDURE UTILIZING A COMPACT SIGMA SN (B)(6).

  Patient problems: Hematoma

  MAUDE report 24570867 ↗
• 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 1037955-2025-00032 ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 22931598 ↗
• 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 COMPACT SIGMA SN (B)(6).

  Patient problems: Hematoma

  MAUDE report 22876680 ↗
• InjuryJun 30, 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 1037955-2025-00026 ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 22357325 ↗
• 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 1037955-2025-00025 ON 06/26/2025.

  Patient problems: Hematoma

  MAUDE report 22343279 ↗
• InjuryJun 6, 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 1037955-2025-00019 ON (B)(6) 2025.

  Patient problems: Hematoma

  MAUDE report 22156447 ↗
• 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 1037955-2024-00009 ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 19071143 ↗
• 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 1037955-2023-00050 ON 12/13/2023.

  Patient problems: Hematoma

  MAUDE report 18324114 ↗
• InjuryDec 13, 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 1037955-2023-00043 ON (B)(6) 2023.

  Patient problems: Hematoma

  MAUDE report 18316367 ↗
• InjuryJul 27, 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 07/20/2023.

  Patient problems: Hematoma

  MAUDE report 17406284 ↗
• InjuryJun 15, 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 1037955-2023-00017 ON 06/08/2023.

  Patient problems: Hematoma

  MAUDE report 17133853 ↗
• InjuryApr 26, 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 16815470 ↗