NA 6207-S5 (UDI 00613994391551)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994391551), received between Aug 9, 2017 and Dec 16, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 13017288 ↗
• 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 13017281 ↗
• MalfunctionJul 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY WHEN SPLITTING THE SHEATH. THE HANDLE SEPARATED FROM THE SHEATH INSTEAD OF FOLLOWING THE TEAR LINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230575 ↗
• MalfunctionJan 4, 2021Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF A PACING LEAD, THE INTRODUCER SHEATH HANDLE BROKE AND BECAME DETACHED DURING THE PEELING PROCESS. AS A RESULT, THE INSULATION OF THE PACING LEAD WAS DAMAGED. THE LEAD WAS TAKEN OUT AND A NEW LEAD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114190 ↗
• MalfunctionOct 28, 2020Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE FOR A PACING LEAD, THE HANDLE OF THE INTRODUCER SNAPPED OFF. THE SHEATH HAD TO BE CUT AWAY RATHER THAN SPLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10747329 ↗
• MalfunctionJan 10, 2019Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING USE THE INTRODUCER WOULD NOT ACCEPT LEAD, AND WAS REMOVED AND FOUND TO HAVE KINKED AND/OR SPLIT WITHIN VEIN. A DIFFERENT INTRODUCER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8238088 ↗
• MalfunctionApr 10, 2018Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE, WHEN THE INITIAL SPLITTING OF THE INTRODUCER THE HUB SEPARATED FROM THE SHEATH BODY DURING THE PEEL THE PHYSICIAN ENCOUNTERED DIFFICULTY TO PART THE INTRODUCER WITH SCISSORS TO REMOVE FROM THE LEAD BODY DURING A PACEMAKER IMPLANT. THIS ADDED CONSIDERABLE TIME TO THE IMPLANT. THE INTRODUCER SHEATH WAS FOUND TO HAVE DIFFICULTY WITH THE PEELING. THE HUB WAS CRACKED AND THE SHEATH WOULD NOT SPLIT ALONG THE SCORE LINE LENGTH WISE. THE INTRODUCER WAS REMOVED AND REPLACED WITH A DIFFERENT INTRODUCER. THE SECOND INTRODUCER ENCOUNTERED THE SAME ISSUE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7413797 ↗
• MalfunctionApr 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE, WHEN THE INITIAL SPLITTING OF THE INTRODUCER THE HUB SEPARATED FROM THE SHEATH BODY DURING THE PEEL THE PHYSICIAN ENCOUNTERED DIFFICULTY TO PART THE INTRODUCER WITH SCISSORS TO REMOVE FROM THE LEAD BODY DURING A PACEMAKER IMPLANT. THIS ADDED CONSIDERABLE TIME TO THE IMPLANT. THE INTRODUCER SHEATH WAS FOUND TO HAVE DIFFICULTY WITH THE PEELING. THE HUB WAS CRACKED AND THE SHEATH WOULD NOT SPLIT ALONG THE SCORE LINE LENGTH WISE. THE INTRODUCER WAS REMOVED AND REPLACED WITH A DIFFERENT INTRODUCER. THE SECOND INTRODUCER ENCOUNTERED THE SAME ISSUE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7413784 ↗
• MalfunctionFeb 8, 2018Break; Break

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE, IT WAS NOTED THAT PATIENT ANATOMY HAD FIBROUS TISSUE IN THE PACE POCKET, AS A RESULT DURING INTRODUCER SHEATH ADVANCE THE PHYSICIAN HAD TO APPLY PRESSURE/FORCE. THE INTRODUCER SHEATH RUPTURED DURING USE, WHILE DILATOR WAS IN THE SHEATH, AND DURING ATTEMPT TO PLACE THE SHEATH OVER THE WIRE. THE INTRODUCER SHEATH WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254634 ↗
• MalfunctionAug 9, 2017Crack; Crack

  IT WAS REPORTED THAT THE INTRODUCER SHEATH WAS FOUND TO BE CRACKED NEAR THE TIP, PRIOR TO INSERTION IN PATIENT'S BODY. THE SHEATH WAS EXCHANGED FOR A DIFFERENT SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780224 ↗