Medusa Multi-Coil MMC-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10857798005017), received between Feb 2, 2016 and May 31, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2019Migration or Expulsion of Device

  REPORTING PHYSICIAN IS DR (B)(6), ASSISTANT PROFESSOR OF MEDICINE, PULMONARY HYPERTENSION PROGRAM, DIVISION OF PULMONARY, CRITICAL CARE, AND SLEEP MEDICINE, UNIVERSITY OF (B)(6). ADDRESS: (B)(6), PHONE: (B)(6), EMAIL: (B)(6). THE DEVICE IS ALLEGED TO HAVE MIGRATED FROM THE LEFT INTERNAL ILIAC VEIN TO THE PULMONARY ARTERY MORE THAN TWO YEARS AFTER IMPLANTATION. TIME OF MIGRATION OCCURRENCE IS ESTIMATED BASED ON ONSET OF PT SYMPTOMS, AND PHYSICIAN REPORTED THE PT HAD IMAGING APPROX ONE YEAR PRIOR WHICH SHOWED THE DEVICE IN THE ORIGINAL IMPLANTED LOCATION. REPORTING PHYSICIAN DID NOT KNOW THE DR OR INSTITUTE FOR ORIGINAL IMPLANTATION, AND DID NOT HAVE IMAGES OF IMPLANTED DEVICE. PT WAS REPORTED AS STABLE AND BEING EVALUATED FOR SURGICAL REMOVAL OF THE DEVICE FROM THE PULMONARY ARTERY. NEW INFO WAS PRESENTED TO MFR IN APRIL 2019 BY LEGAL REP OF PT, INDICATING PT WAS INITIALLY TREATED BY PRIMARY CARE PHYSICIAN IN (B)(6) 2018 FOR CONGESTION, COUGH, AND SHORTNESS OF BREATH. CT SCAN PERFORMED IN (B)(6) 2018 INDICATED "COIL-LIKE METALLIC STRUCTURE IN THE RIGHT BASILAR LOBE PULMONARY ARTERIES." AN ATTEMPT TO REMOVE THE DEVICE WAS PERFORMED AT (B)(6) HOSPITAL ON (B)(6) IN (B)(6) 2018 WITHOUT

  Patient problems: Foreign Body In Patient

  MAUDE report 8662451 ↗
• MalfunctionMar 28, 2017Premature Activation; Premature Activation

  THE DEVICE DID NOT FORM THE EXPECTED COIL PACK WHEN FIRST PARTIALLY DEPLOYED IN AN ESTIMATED 15.8 MM VENOUS ANEURYSM. THE DEVICE WAS PARTIALLY DEPLOYED FARTHER THAN IS RECOMMENDED BEFORE RETRACTION. THE PHYSICIAN RETRACTED THE DEVICE, REPOSITIONED, AND DEPLOYED AGAIN. DURING THIS SECOND ATTEMPT, THE DEVICE BECAME COMPLETELY DETACHED, PRESENTING AN EMBOLISM RISK. THE PHYSICIAN HELD THE DEVICE IN PLACE AND PLACED THREE SUTURES TO IMMOBILIZE THE DEVICE. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6440218 ↗
• InjuryFeb 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TREATED WITH MMC-122 EMBOLIZATION DEVICE FOR VENOUS INSUFFICIENCY ON (B)(6) 2015. DEEP VEIN THROMBOSIS DIAGNOSED ON (B)(6) 2015. PATIENT GIVEN WARFARIN AND FOLLOWED FOR TWO WEEKS. NO PERMANENT IMPAIRMENT.

  Patient problems: Thrombosis

  MAUDE report 5405480 ↗