NA 6207-S1 (UDI 00643169646155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169646155), received between Jun 9, 2021 and Aug 12, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218934 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT PRIOR TO IMPLANT IT WAS NOTICED THAT THE HEAD OF THE INTRODUCER IS DETACHED FROM THE BODY. 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 19688935 ↗
• MalfunctionApr 29, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT WHEN THE PHYSICIAN WANTED TO REMOVE THE INTRODUCER BY PEELING IT, THE INTRODUCER BROKE. IT WAS PARTIALLY PEELED AND TO REMOVE IT COMPLETELY THE PHYSICIAN NEEDED TO SLIT IT WITH THE SLITTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201140 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING THE IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE INTRODUCER WAS SPLIT. THE INTRODUCER WAS 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 18028361 ↗
• MalfunctionDec 16, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE WING SNAPPED OFF NOT ALLOWING THE INTRODUCER TO PEEL AWAY AS IT SHOULD. THE 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 13017297 ↗
• MalfunctionJun 9, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE, THE INTRODUCER FELL TO GROUND COMPROMISING IT'S STERILITY AS ONE SIDE OF THE PLASTIC PACKAGING BAG WAS OPEN WHEN IT WAS TAKEN OUT OF THE CARTON. THE INTRODUCER WAS 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 11966587 ↗