Coil Pusher-16 M0014012160Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729158967), received between Jan 8, 2019 and Feb 24, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JAN2025. IT WAS REPORTED THAT THE TIP OF THE DEVICE WAS KINKED. THE TARGET LESION WAS LOCATED IN THE PELVIS. A 177CM COIL PUSHER -16 COIL WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS KINKED UPON UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL SECTION WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453295 ↗
• InjuryNov 19, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT A RETAINED MATERIAL WAS IDENTIFIED INSIDE THE PATIENT'S BODY. THE PATIENT UNDERWENT LEFT GONADAL VEIN EMBOLIZATION USING A 177CM COIL PUSHER-16 COIL. DURING THE PROCEDURE, THE COIL DID NOT DEPLOY AS USUAL, REQUIRING THE PHYSICIAN TO MANIPULATE THE COIL TO COMPLETE THE DEPLOYMENT. AT THE TIME, THERE WAS NO INDICATION THAT THE DEVICE WAS DAMAGED OR THAT THE PATIENT RETAINED ANY MATERIAL. THE PROCEDURE WAS COMPLETED AS INTENDED, AND THE DEVICE WAS DISCARDED AFTER THE PROCEDURE AS PER THE USUAL PROCESS. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED THE SAME DAY. HOWEVER, THREE MONTHS FOLLOWING THE EMBOLIZATION PROCEDURE, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN AT A PRIVATE RADIOLOGY SERVICE. IT WAS NOTED THAT A RETAINED MATERIAL HAD BEEN IDENTIFIED, WHICH WAS LIKELY FROM THE EMBOLIZATION PROCEDURE. THE PATIENT IS CURRENTLY SEEKING MEDICAL ADVICE REGARDING THE RETAINED MATERIAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20727820 ↗
• MalfunctionSep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16AUG2024. A 177CM COIL PUSHER-16 WAS RETURNED WITH NO REPORTED ISSUES. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170712 ↗
• InjuryAug 14, 2024Break; Break

  IT WAS REPORTED THAT COIL PUSHER BREAK OCCURRED, AND A FRAGMENT REMAINED INSIDE THE PATIENT, REQUIRING ADDITIONAL INTERVENTION. A 177 CM COIL PUSHER-16 WAS SELECTED FOR USE TO PUSH THE UNKNOWN COIL THROUGH THE CATHETER. DURING REMOVAL, THERE WAS RESISTANCE IN RETRACTING AND WHEN REMOVED, IT WAS NOTICED THAT A FRAGMENT FROM THE END OF THE PUSHER HAD SNAPPED OFF AND DISLODGED IN THE PATIENT. THE DEVICE FRAGMENT WAS CAGED WITH COILS TO AVOID MIGRATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LEFT GONADAL (TESTICULAR) VEIN. THE FRAGMENT WAS RETAINED IN THE SAME VEIN (LEFT GONADAL VEIN) THAT WAS EMBOLIZED AS PLANNED USING NON-BOSTON SCIENTIFIC COILS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19986714 ↗
• MalfunctionMar 24, 2021Break; Break

  IT WAS REPORTED THAT THE COIL PUSHER BROKE. A 177CM COIL PUSHER-16 WAS SELECTED FOR USE IN A COILING EMBOLIZATION PROCEDURE IN THE PELVIS WITH 45 DEGREES OF TORTUOSITY. DURING THE PROCEDURE, WHILE PUSHING THE SECOND COIL FORWARD, THE COIL PUSHER BROKE IN TWO PIECES INSIDE THE CATHETER. BOTH PIECES OF THE COIL PUSHER WERE EASILY REMOVED FROM THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER COIL PUSHER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11560054 ↗
• MalfunctionJan 8, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INNER PACKAGE WAS BLOTTED. THE INNER PACKAGE OF A 177CM COIL PUSHER - 16 WAS BLOTTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8228718 ↗