NA 6057-58 (UDI 00681490140003)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490140003), received between Jul 15, 2020 and Oct 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO USE THE STYLETS STERILE BARRIER WAS BREACHED. IT WAS NOTED THAT A CONTAINER WITH A BAG OF ICE WAS INADVERTENTLY LEFT NEAR STYLETS AND ICE SEEPED INTO THE STYLET PACKAGING. IT WAS NOTED THAT WATER INSULATION WAS FOUND IN STYLET PACKAGING. THE STYLETS WERE ATTEMPTED/NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23400776 ↗
• MalfunctionJul 15, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PACING LEAD HELIX WAS NOT SMOOTHLY EXTENDED AND MOVEMENT OF THE HELIX BECAME EXTREMELY DULL. IT WAS FURTHER REPORTED THAT THE INSERTION OF A STYLET BECAME DIFFICULT. IT WAS ALSO REPORTED THAT THE PACING LEAD THRESHOLDS WERE NOT FAVOURABLE. THE PACING LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10274710 ↗