NA C320LBBL45 (UDI 00763000747459)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000747459), received between May 13, 2026 and Jun 2, 2026 — classified as 6 malfunctions.

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

• MalfunctionJun 2, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT WHILST THE PHYSICIAN WAS SLITTING , THE CATHETER BROKE OFF AFTER THEY GOT PAST THE HUB. THE PHYSICIAN WAS ABLE TO GRAB THE CATHETER WITH AN INSTRUMENT AND HOOK THE CATHETER BACK INTO THE SLITTER AND SLIT THE REST OF THE WAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359692 ↗
• MalfunctionMay 21, 2026Accessory Incompatible

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED DURING IMPLANT. IT WAS FURTHER NOTED THAT THE RV LEAD WAS PLACED IN THE LEFT BUNDLE AREA, DURING SLITTING, THE SEALING RING OF THE CATHETER WAS NOT CUT AND REMAINED AROUND THE LEAD BODY. THE LEAD AND CATHETER 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 25239618 ↗
• MalfunctionMay 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT THAT WHEN THEY BEGAN SLITTING THE CATHETER SHAFT WHEN THEY NOTICED THAT THE ENTIRE CATHETER HANDLE (PROXIMAL END) WAS SEVERED FROM THE CATHETER BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230342 ↗
• MalfunctionMay 20, 2026Material Integrity Problem

  IT WAS REPORTED DURING IMPLANT THAT AFTER SUCCESSFUL PLACEMENT OF THE LEAD IN THE LEFT BUNDLE AREA, DURING SLITTING, THE SEALING RING OF THE CATHETER WAS NOT CUT AND REMAINED AROUND THE LEAD BODY WHICH RESULTED TO THE LEAD DISLODGEMENT. THE CATHETER WAS ATTEMPTED BUT 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 25230270 ↗
• MalfunctionMay 18, 2026Break; Material Integrity Problem

  IT WAS REPORTED DURING IMPLANT THAT THE CATHETER BROKE INTO TWO SEPARATE PIECES UPON SLITTING RESULTING IN HALF OF THE CATHETER BEING LEFT IN THE INTRODUCER REQUIRING SEPARATE PIECES NEEDING TO BE SLIT. THE CATHETER WAS ATTEMPTED BUT 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 25198228 ↗
• MalfunctionMay 13, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT THE CATHETER BROKE IN HALF DURING SLIT. THE CATHETER WAS ATTEMPTED AND NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159834 ↗