2D Helical - 35 M0013726040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729237259), received between Dec 19, 2017 and Nov 26, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 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.

• MalfunctionNov 26, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE COIL WAS EXPIRED. ON (B)(6) 2018, A 6MMX 40MM 2D HELICAL - 35 THAT HAS AN EXPIRATION DATE OF 31JUL2018 WAS IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102964 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED POST IMPLANT. A 2D HELICAL ¿ 35 COIL WAS SUCCESSFULLY IMPLANTED IN THE COLLATERAL VEIN FROM AN AV FISTULA. THREE DAYS POST IMPLANT DURING THE FOLLOW UP, THE PATIENT COMPLAINED ABOUT SOME PAIN, REDNESS, IRRITATION AND SWELLING IN THE AREA THAT WAS COILED. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL TREATMENT. THIRTEEN DAYS POST IMPLANT THE PATIENT¿S PAIN SUBSIDED, HOWEVER; THE COILED AREA WAS STILL RAISED AND SLIGHTLY DISCOLORED. THE PATIENT WAS BACK TO DOING NORMAL ACTIVATES.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Skin Discoloration; Swelling

  MAUDE report 7128584 ↗
• InjuryDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED POST IMPLANT. A 2D HELICAL ¿ 35 COIL WAS SUCCESSFULLY IMPLANTED IN THE COLLATERAL VEIN FROM AN AV FISTULA. DURING THE NEXT DAY FOLLOW UP, THE PATIENT COMPLAINED ABOUT SOME REDNESS AND IRRITATION IN THE AREA THAT WAS COILED. THE PATIENT DID NOT RECEIVE ANY ADDITIONAL TREATMENT AND THE EVENT WAS RESOLVING AND THE PATIENT WAS BACK TO DOING NORMAL ACTIVATES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7128057 ↗