One-Tie G31929Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002319295), received between Jul 29, 2021 and Aug 13, 2026 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 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.

• DeathAug 13, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Cook Customer Relations by Merit Medical Systems, Inc.: Customer reports they had a lead extraction. This was a second attempt after failing a lead extraction on the previous Saturday. Patient was very sick and had an infection and lots of other co-morbidities. They began the extraction with a few different tools, Byrd Dilator Sheaths, Philips Laser, 9Fr Evolution. They were able to remove the left ventricle (LV) lead but still needed to remove the right ventricle (RV) lead. They tried with the same tools and also upsized to a 13Fr Evolution, and larger laser tool with no success of removal of the RV lead. The patient's vitals were not at a safe point to keep working on them, so they decided it was best to stop where we were and possibly bring him back and approach it from a femoral removal and use medical therapy in the short term to manage infection. As they were closing the groin and pocket area the patient began decompensating and they looked under echo and saw that the heart was slowing down and beginning to clot off and "[the patient]" ultimately expired. They confirmed that this had nothing to do with the devices themselves but just

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50238316 ↗
• DeathApr 15, 2026Adverse Event Without Identified Device or Use Problem

  A MERIT MEDICAL EMPLOYEE CONDUCTED A POST-MARKET CLINICAL FOLLOW UP (PMCF) REVIEW FOR THE MERIT LEAD SUPPORT DEVICES. MERIT MEDICAL THEN FORWARDED THE STUDY INFORMATION TO COOK MEDICAL. THE REFERENCED JOURNAL ARTICLE/STUDY ("TRANSVENOUS LEAD EXTRACTION: EXPERIENCE OF THE TANDEM APPROACH", AKHTAR, ET AL.) DESCRIBES THE USE OF A TANDEM APPROACH DURING TRANSVENOUS LEAD EXTRACTION PROCEDURES IN PATIENTS WITH CHRONICALLY IMPLANTED CARDIAC DEVICES WITH LEADS. THE ONE-TIE COMPRESSION COIL WAS USED TO STABILIZE THE LEAD AND IMPROVE TRACTION DURING EXTRACTION. COMPLICATIONS REPORTED INCLUDE KNOWN EXTRACTION RISKS SUCH AS VASCULAR INJURY, PERICARDIAL EFFUSION, AND PROCEDURAL COMPLICATIONS RELATED TO LEAD EXTRACTION. NO DEVICE MALFUNCTION OR PERFORMANCE ISSUES ASSOCIATED WITH THE ONE-TIE COMPRESSION COIL WERE REPORTED. HOWEVER, ONE PROCEDURE INVOLVING A 61-YEAR-OLD FEMALE LEAD TO A TEAR IN THE SUPERIOR VENA CAVA TO RIGHT ATRIUM (SVC-RA) JUNCTION RESULTING IN PERICARDIAL TAMPONADE. THIS EVENT REQUIRED STERNOTOMY AND REPAIR OF THE INJURY. THE PATIENT DIED TWO DAYS POST PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24887545 ↗
• InjuryJul 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PHYSICIAN MADE LEAD CONTROL IN THE RIGHT ATRIAL LEAD WITH LIBERATOR, ONE-TIE, AND EVOLUTION SHORTIE 9 FRENCH. ACCESS FOR PROCEDURE WAS GAINED FROM THE LEFT SUBCLAVIAN VEIN. AFTER THE TIP OF THE LEAD WAS REMOVED, LEAD EXTRACTION WAS ATTEMPTED USING A SNARE (OTHER MANUFACTURER) WITH A FEMORAL APPROACH. AFTER GRASPING THE TIP OF THE LEAD WITH THE SNARE, THE PHYSICIAN CONFIRMED THAT THE LEAD COMING OUT OF THE UPPER LIMB AND THE PORTION HELD BY THE SNARE WERE PULL-THROUGH, WITHOUT ADHESIONS IN THE MIDDLE. HOWEVER, THE PATIENT'S SIDE (DISTAL END OF THE ONE-TIE) SHOULD HAVE BEEN CUT OFF, BUT THE SURGEON'S SIDE (PROXIMAL END OF THE ONE-TIE) WAS CUT OFF INSTEAD. AS A RESULT, THE LEAD WITH THE ONE-TIE ATTACHED WAS PULLED INTO THE FEMORAL REGION BY THE SNARE. ANOTHER PHYSICIAN WHO WAS AT THE SIDE OF THE LOWER EXTREMITY INSERTED A 16FR SHEATH FROM THE INGUINAL REGION. THE 16FR SHEATH WAS REMOVED AND THE THICKENED LEAD WITH ATTACHED ONE-TIE WAS UNABLE TO PASS THROUGH THE PUNCTURE SITE AND BECAME STUCK. THE PHYSICIAN TRIED UNSUCCESSFULLY TO INTRODUCE THE ONE-TIE INTO COOK'S BYRD DILATOR SHEATH VIA THE INGUINAL LEAD, THEREFORE THE TRANSVENOUS APPROACH WAS ABANDONED. A VAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247021 ↗