MReye G42423Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002424234), received between May 11, 2018 and Jan 18, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• MalfunctionJan 18, 2022Migration; Migration

  IN ADDITIONAL INFORMATION RECEIVED ON 04MAR2022, IT WAS REPORTED THAT THE ANATOMICAL TARGET VESSEL WAS THE LEFT HYPOGASTRIC VEIN, 9MM. ONE YEAR LATER, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND INCIDENTAL COIL IN A PULMONARY ARTERY BRANCH. COIL MIGRATION WAS ORIGINALLY DISCOVERED ON 24DEC2021. EVALUATION BY INTERVENTIONAL RADIOLOGY FOR POSSIBLE RETRIEVAL WAS DONE AT THE FACILITY, BUT WAS DECLINED BY THE PATIENT. THE PATIENT BELIEVES THAT THEIR CHEST PAIN AND RECURRENT LEG SWELLING RESULTED FROM THIS EMBOLIZATION AND IS SEEKING A SECOND OPINION FOR RETRIEVAL. NO ANTICOAGULATION MEDICATIONS ARE BEING USED BY THE PATIENT.

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 13285434 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2017 A PATIENT THAT UNDERWENT GONADAL VEIN EMBOLISATION (LEFT SIDE VARICOCELE) WAS SUFFERING FROM LOCALIZED PAIN AT THE SURGICAL SITE. ON (B)(6) 2018, THE PATIENT REPORTED HE STILL HAD COMPLICATION/PAIN IN THE SURGICAL AREA. AT THIS TIME, THE PATIENT¿S MEDICAL TEAM DETERMINED HE DEVELOPED AN ALLERGIC REACTION TO THE IMPLANTED COILS/FIBERS. THE TEAM STATED THEY ARE PLANNING TO REMOVE THE COILS AND/OR HIS GONADAL VEIN WITH ASSOCIATED OR AFFECTED ORGANS. ON (B)(6) 2018, SPECIFIC DEVICES, LOTS AND QUANTITIES OF THE IMPLANTED COILS WERE REPORTED. AS REPORTED, A TOTAL OF 33 VARIOUS COOK INC. COILS AND AN UNSPECIFIED AMOUNT OF COMPETITOR COILS WERE IMPLANTED TWO MONTHS BEFORE (B)(6) 2017. THE FOLLOWING MEDWATCH REPORTS ARE FOR COILS IMPLANTED IN THIS SAID PATIENT. MEDWATCH 1820334-2018-01398 ¿ LOT 7423636 ¿ QUANTITY 5 DEVICES; MEDWATCH 1820334-2018-01399 ¿ LOT 7292138 ¿ QUANTITY 4 DEVICES; MEDWATCH 1820334-2018-01400 ¿ LOT 7815839 ¿ QUANTITY 3 DEVICES; MEDWATCH 1820334-2018-03888 ¿ LOT 7858778 ¿ QUANTITY 6 DEVICES; MEDWATCH 1820334-2018-01389 ¿ LOT 7698119 ¿ QUANTITY 7 DEVICES; MEDWATCH 1820334-2018-01390 ¿ LOT 7262416 ¿ QUANTITY 8 DEVICES.

  Patient problems: Foreign Body Reaction

  MAUDE report 7506528 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2017 A PATIENT THAT UNDERWENT GONADAL VEIN EMBOLISATION (LEFT SIDE VARICOCELE) WAS SUFFERING FROM LOCALIZED PAIN AT THE SURGICAL SITE. ON (B)(6) 2018, THE PATIENT REPORTED HE STILL HAD COMPLICATION/PAIN IN THE SURGICAL AREA. AT THIS TIME, THE PATIENT¿S MEDICAL TEAM DETERMINED HE DEVELOPED AN ALLERGIC REACTION TO THE IMPLANTED COILS/FIBERS. THE TEAM STATED THEY ARE PLANNING TO REMOVE THE COILS AND/OR HIS GONADAL VEIN WITH ASSOCIATED OR AFFECTED ORGANS. ON 04/24/2018, SPECIFIC DEVICES, LOTS AND QUANTITIES OF THE IMPLANTED COILS WERE REPORTED. AS REPORTED, A TOTAL OF 33 VARIOUS COOK INC. COILS AND AN UNSPECIFIED AMOUNT OF COMPETITOR COILS WERE IMPLANTED TWO MONTHS BEFORE (B)(6) 2017. THE FOLLOWING MEDWATCH REPORTS ARE FOR COILS IMPLANTED IN THIS SAID PATIENT. MEDWATCH 1820334-2018-01398 ¿ LOT 7423636 ¿ QUANTITY 5 DEVICES, MEDWATCH 1820334-2018-01399 ¿ LOT 7292138 ¿ QUANTITY 4 DEVICES, MEDWATCH 1820334-2018-01400 ¿ LOT 7815839 ¿ QUANTITY 3 DEVICES, MEDWATCH 1820334-2018-03888 ¿ LOT 7858778 ¿ QUANTITY 6 DEVICES, MEDWATCH 1820334-2018-01389 ¿ LOT 7698119 ¿ QUANTITY 7 DEVICES, MEDWATCH 1820334-2018-01390 ¿ LOT 7262416 ¿ QUANTITY 8 DEVICES.

  Patient problems: Foreign Body Reaction

  MAUDE report 7506449 ↗