NA 6207-S1 (UDI 00681490143011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00681490143011), received between Aug 9, 2017 and Nov 21, 2023 — classified as 2 deaths, 3 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING IMPLANT THAT THE LEAD INTRODUCER "GRIP TABS HAD DETACHED WHEN STARTING TO PEEL THE SHEATH". THE SHEATH WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180185 ↗
• MalfunctionOct 13, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPLANT IT WAS NOTICED AFTER OPENING THE PACKAGE THAT THE INTRODUCER WAS CRACKED IN THE MIDDLE. THE INTRODUCER WAS OPENED/NOT USED. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15593759 ↗
• MalfunctionJun 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A PACEMAKER IMPLANT PROCEDURE THE INTRODUCER BODY WAS NOTED TO BE BROKEN AND IT WAS DIFFICULT TO USE IN THE PATIENT DUE TO LACK OF SUPPORT TO ADVANCE IT IN THE VEIN. THE INTRODUCER WAS ATTEMPTED/ NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686573 ↗
• MalfunctionMay 31, 2022Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE INTRODUCER BROKE OPEN DURING INSERTION. A REPLACEMENT INTRODUCER WAS USED AND THE SAME ISSUE OCCURRED. THE INTRODUCER WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545909 ↗
• MalfunctionJan 24, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THAT THE INTRODUCER WAS BROKEN. THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13332044 ↗
• MalfunctionDec 7, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A PACING LEAD THE SHEATH OF A INTRODUCER TEARED UNEVENLY AND DIDN'T GO INSIDE THE VEIN. THE INTRODUCER WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12949384 ↗
• MalfunctionSep 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED DURING AN IMPLANT PROCEDURE. THE INTRODUCER WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510557 ↗
• MalfunctionSep 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED DURING AN IMPLANT PROCEDURE. THE INTRODUCER WAS RETURNED TO THE MANUFACTURER AND SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510538 ↗
• MalfunctionSep 16, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN ATTEMPTED TO PEEL THE SHEATH AFTER LEAD WAS FIXED. THE PRODUCT ¿ARM¿ DETACHED FROM SHEATH INSTEAD OF PEELING. THE PHYSICIAN USED THEIR FINGERS TO COMPLETE PEELING THE SHEATH AWAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479401 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT DURING IMPLANT THE LEAD INTRODUCER SNAPPED. NECESSITATING THE USE OF A CATHETER SPLITTER TO REMOVE THE BROKEN INTRODUCER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324091 ↗
• MalfunctionAug 11, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING IMPLANT THE LEAD INTRODUCER EXHIBITED A KINK AFTER THE REMOVAL OF THE DILATOR AND WAS CREATING RESISTANCE FOR LEAD INSERTION. THE LEAD INTRODUCER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308570 ↗
• MalfunctionJul 9, 2021Break; Break

  IT WAS REPORTED THAT THE PHYSICIAN WAS TRYING TO DILATE VEIN MANY TIMES BUT SHEATH GOT KINKED. IT WAS FURTHER REPORTED THAT THE INTRODUCER BROKE DURING THE IMPLANT PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141908 ↗
• MalfunctionJun 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE, THE INTRODUCER WAS FAULTY WAS QUITE WEAK, EASILY COLLAPSIBLE AND TEARS OUT ON INSERTION. THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12031568 ↗
• MalfunctionMay 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE TRYING TO PEEL THE INTRODUCER AND GRASP IT IN THE PROXIMAL AREA, THE PEEL BROKE PREVENTING FURTHER PEELING. IT WAS NECESSARY TO USE SCISSORS LITTLE BY LITTLE TO BE ABLE TO REMOVE THE PEEL. IT WAS NOTED THIS OCCURRED WITH TWO INTRODUCERS. IT WAS ALSO REPORTED ONE OF THE INTRODUCERS WAS "SEND PEELED" AND THE OTHER WAS NOT CUT DUE TO THE DAMAGE OCCURRING DURING USE. THE INTRODUCERS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797277 ↗
• MalfunctionMay 10, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE TRYING TO PEEL THE INTRODUCER AND GRASP IT IN THE PROXIMAL AREA, THE PEEL BROKE PREVENTING FURTHER PEELING. IT WAS NECESSARY TO USE SCISSORS LITTLE BY LITTLE TO BE ABLE TO REMOVE THE PEEL. IT WAS NOTED THIS OCCURRED WITH TWO INTRODUCERS. IT WAS ALSO REPORTED ONE OF THE INTRODUCERS WAS "SEND PEELED" AND THE OTHER WAS NOT CUT DUE TO THE DAMAGE OCCURRING DURING USE. THE INTRODUCERS WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797262 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT DURING INSERTION OF THE LEAD BY INTRODUCER, IT WOULD NOT ADVANCE. WHEN CHECKED, A RUPTURE OF THE INTRODUCER BODY WAS OBSERVED. THE INTRODUCER WAS NOT USED AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782102 ↗
• InjuryApr 15, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DURING IMPLANT OF THE PACING LEAD, THE INTRODUCER WAS NOT LONG ENOUGH AND AFTER MULTIPLE MANIPULATIONS WITH THE PACING LEAD, THE INTRODUCER PERFORATED THE SUBCLAVIAN ARTERY, CAUSING A PLEURAL EFFUSION. A THORACENTESIS WAS PERFORMED TO REMOVE THE EXCESS FLUID. THE PACING LEAD WAS ATTEMPTED/NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11671316 ↗
• MalfunctionFeb 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, DURING SPLITTING OF THE INTRODUCER, ONE OF THE HANDLES OF THE INTRODUCER BROKE AWAY FROM THE INTRODUCER BODY WHEN PEELING THE INTRODUCER, THUS MAKING IT IMPOSSIBLE TO SPLIT THE INTRODUCER PROPERLY. THE REMAINING INTRODUCER MATERIAL REMOVED FROM THE PACING LEAD WITHOUT DAMAGE TO THE LEAD OR PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327671 ↗
• MalfunctionFeb 11, 2021Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER THE IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THE PHYSICIAN PEELED AWAY THE INTRODUCER, BUT IT DID NOT PEEL COMPLETELY. DUE TO THIS THE PHYSICIAN HAD TO PEEL THE INTRODUCER MANUALLY AND DURING THIS PROCESS, THE RA LEAD INSULATION WAS DAMAGED FROM CONTACT WITH SURGICAL FORCEPS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313596 ↗
• MalfunctionJan 21, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207442 ↗
• MalfunctionJan 21, 2021Break; Break

  IT WAS FURTHER REPORTED THAT THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207441 ↗
• MalfunctionJan 7, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A PACING LEAD, THE SHEATH OF THE INTRODUCER COULD NOT BE PEELED/SPLIT AS THE HANDLE WAS REMOVED, THEREFORE IT HAD TO BE CUT WITH A MEDICAL TOOL. ANOTHER INTRODUCER WAS USED, HOWEVER THE SAME ISSUE WAS ENCOUNTERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133683 ↗
• MalfunctionJan 7, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A PACING LEAD, THE SHEATH OF THE INTRODUCER COULD NOT BE PEELED/SPLIT AS THE HANDLE WAS REMOVED, THEREFORE IT HAD TO BE CUT WITH A MEDICAL TOOL. ANOTHER INTRODUCER WAS USED, HOWEVER THE SAME ISSUE WAS ENCOUNTERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133655 ↗
• InjuryDec 7, 2020Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE. THE PACING LEAD TO THE PASSAGE OF THE VEIN SHOWED A LITTLE RESISTANCE TO ITS PASSAGE WITH THE INTRODUCER REQUIRING FORCE, BUT WHEN THE DILATOR IS WITHDRAWN TO PASS THE LEAD IT DID NOT PROVIDE SUPPORT AND CAUSED SILICONE INSULATION TO WRINKLES MAKING IT DIFFICULT FOR PASSAGE OF THE LEAD TO THE HEART AND DAMAGING THE STYLETS. IT WAS NOTED THAT THE PATIENT BLEED MORE THAN NORMAL AND HAD TO RE-PUNCTURE THE VEIN DUE TO THE DIFFICULTY OF SUPPORTING THE INTRODUCERS. IT WAS NOTED THAT IT FELT AS IF THE INTERNAL DIAMETER OF THE INTRODUCER WAS LESS THAN THE DIAMETER OF THE LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10957677 ↗
• InjuryDec 7, 2020Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE. THE PACING LEAD TO THE PASSAGE OF THE VEIN SHOWED A LITTLE RESISTANCE TO ITS PASSAGE WITH THE INTRODUCER REQUIRING FORCE, BUT WHEN THE DILATOR IS WITHDRAWN TO PASS THE LEAD IT DID NOT PROVIDE SUPPORT AND CAUSED SILICONE INSULATION TO WRINKLES MAKING IT DIFFICULT FOR PASSAGE OF THE LEAD TO THE HEART AND DAMAGING THE STYLETS. IT WAS NOTED THAT THE PATIENT BLEED MORE THAN NORMAL AND HAD TO RE-PUNCTURE THE VEIN DUE TO THE DIFFICULTY OF SUPPORTING THE INTRODUCERS. IT WAS NOTED THAT IT FELT AS IF THE INTERNAL DIAMETER OF THE INTRODUCER WAS LESS THAN THE DIAMETER OF THE LEAD. NO FURTHER PATIENT COMPLICATIONS BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10957672 ↗