NA 6207-S5 (UDI 00643169646278)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169646278), received between May 7, 2021 and Jun 13, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE, THE NEEDLE SNAPPED OFF WHEN NEEDLE WAS BENT DURING PREP AND PRIOR TO USE. INTRODUCER WAS NEVER 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 22202448 ↗
• MalfunctionNov 29, 2024Break; Break

  IT WAS REPORTED THAT DURING IMPLANT WHEN THE PHYSICIAN APPLIED PRESSURE TO PULL BACK THE INTRODUCER THE WIRE SNAPPED WHEN THE OUTER COIL SNAPPED. A SMALL PIECE OF THE DISTAL PORTION OF THE INTRODUCER THAT WAS STICKING OUT OF THE ACCESS POINT WAS CUT OFF BY THE PHYSICIAN AS IT WAS FRAYED. 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 20809074 ↗
• MalfunctionJan 11, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF TWO PACING LEADS , WHILST PEELING THE INTRODUCER SHEATHS , THE PLASTIC TIP OF THE INTRODUCERS BROKE PREVENTING PEELING. THE INTRODUCERS WERE ATTEMPTED/ NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499500 ↗
• MalfunctionJan 11, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF TWO PACING LEADS , WHILST PEELING THE INTRODUCER SHEATHS , THE PLASTIC TIP OF THE INTRODUCERS BROKE PREVENTING PEELING. THE INTRODUCERS WERE ATTEMPTED/ NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499488 ↗
• InjuryDec 22, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLEEDING. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTED THAT THERE WERE DIFFICULTIES MANIPULATING THE INTRODUCER AND THERE WERE SIGNIFICANT BLOOD LEAKS WHILE USING THE INTRODUCER AND THE AMOUNT OF BLOOD LEAKING OBSERVED WAS ABNORMAL FOR ITS INTENDED USE. THE INTRODUCER WAS ATTEMPTED/NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18382810 ↗
• MalfunctionApr 5, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE ONE OF THE TABS BROKE OFF THE INTRODUCER WHEN SPLITTING THE SHEATH, REQUIRING IT TO BE CUT WITH SCISSORS.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14011019 ↗
• MalfunctionMar 20, 2022Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SHEATHS HANDLE BROKE OF RESULTING ON LOOSE PARTS OF THE SHEATH IN THE WOUND. THE SHEATH THEN HAD TO BE REMOVED BY SLITTING IT WITH SCISSORS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830759 ↗
• MalfunctionNov 8, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SHEATH OF THE INTRODUCER WOULD NOT PEEL, THE PHYSICIAN HAD TO CUT THE INTRODUCER TO REMOVE IT WITHOUT DISPLACING THE LEAD. THE LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12768358 ↗
• MalfunctionMay 13, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE INTRODUCER SHEATH DID NOT PEEL AWAY PROPERLY. THE PHYSICIAN USED SCALPEL TO CUT IT AND FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11823210 ↗
• MalfunctionMay 7, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO SPLIT THE LAST 3 MM OF INTRODUCER SHEATH. IT HAD TO BE CUT WITH SCISSORS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793862 ↗