Mara DDK-16-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888937026887), received between Oct 11, 2022 and Jun 12, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MARA ABLATION PROCEDURE ON (B)(6) 2024. FIVE WEEKS POST PROCEDURE, THE PATIENT UNDERWENT A HYSTERECTOMY DUE TO A SIGNIFICANT UTERINE INFECTION. DOCTOR UNSURE IF THE INFECTION IS RELATED TO THE MARA PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. . DDK-16-050 MARA PROBE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519438 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185673 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084781 ↗
• MalfunctionOct 11, 2022Leak/Splash; Leak/Splash

  ACCOUNT SAID THAT THEY SET UP FOR THE PROCEDURE AND ONCE THEY GOT TO THE PROBE SELF TEST ALERT 176 CAME UP ON THE SCREEN. THEY NEVER GOT TO THE FIRST CHECK MARK ON THE PROBE SELF TEST. THEY MADE SURE THE PROBE WAS SECURE IN THE CARTRIDGE. DR. MAZLIN SAID THAT SALINE WAS GOING INTO THE PROBE COVER AND BEGAN LEAKING OUT. AFTER THEY HIT CLEAR ON THE ALERT IT WOULD BRING THEM BACK TO THE PROBE SELF TEST. SAME THING WOULD HAPPEN. THEY NEVER GOT TO THE FIRST CHECK MARK. THE ACCOUNT SWITCHED OUT THE PROBE AND TRIED AGAIN WITH THE SAME ALERT APPEARING ON THE SCREEN. AFTER SEVERAL MORE ATTEMPTS THEY ABORTED THE PROCEDURE. ONCE THE SYRINGE WAS UNLOCKED FROM THE TOP OF THE MARA CONSOLE THEY NOTICED SALINE AT THE VERY BOTTOM. THE MA DRIED IT UP WITH GAUZE. I WENT TO THE ACCOUNT AND CHECKED TO SEE IF EITHER PROBE WAS LEAKING FROM THE BOTTOM OF THE SYRINGE. BOTH SEEMED TO BE SECURE. I OPENED ONE OF MY DEMO PROBES TO ENSURE THE CONSOLE WAS NOT DAMAGED. I WAS ABLE TO RUN THROUGH THE PROBE SELF TEST WITHOUT ANY ISSUES. I DID RECEIVE AN ALERT 101. I HIT CLEAR AND I WAS ABLE TO PROCEED THROUGH THE INTEGRITY AND PATENCY TESTS WITH OUT ISSUE. MARA CONSOLE SEEMS TO BE WORKING OK AFTER THE UNSUCCESSFUL P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575314 ↗