NA C320LBBS45 (UDI 00763000747473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000747473), received between Mar 26, 2026 and Sep 22, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component; Material Integrity Problem

  It was reported that intraoperative the proximal end of the guiding catheter fell off when slitting. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854358 ↗
• MalfunctionSep 22, 2026Material Integrity Problem

  It was reported that intraoperative slitting the guiding catheter was challenging at the hub. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852751 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  It was reported that during implant the catheter broke while slitting. No patient complications have been reported as a result of th is event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840157 ↗
• MalfunctionSep 21, 2026Detachment of Device or Device Component

  It was reported that during implant the catheter separated. The lead 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 50836684 ↗
• MalfunctionSep 11, 2026Break

  It was reported that during implant the lead catheter hub detached during slitting. The lead was attempted not used. No patient comp lications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727620 ↗
• MalfunctionSep 9, 2026Material Integrity Problem

  It was reported that during the implant procedure the hemostatic valve would not slit. The delivery catheter 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 50692238 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that intra-operatively the catheter hub separated from the shaft at the beginning of slitting. The physician has nothing to hold onto to continue slitting. The catheter was used. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50473047 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that introperative the hub of the delivery catheter snapped off during slitting. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50471814 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222500 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  It was reported that during implant, the delivery catheter  split in half during slitting. The delivery catheter was attempted but not used. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218533 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158164 ↗
• MalfunctionJun 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED INTRAOPERATIVELY THAT THE CATHETER VALVE CAME OUT WHILE ATTEMPTING TO INSERT THE PACING LEAD. THE 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 25543756 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT THE CATHETER RIPPED IN HALF LATERALLY AS IT WAS BEING SLIT RESULTING IN THE CATHETER DETACHING. THE CATHETER WAS NOT SUED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25531870 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED DURING THE IMPLANT PROCEDURE, THE CATHETER BROKE DURING SLITTING. THE CATHETER AND SLITTER 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 25392972 ↗
• MalfunctionJun 3, 2026Break

  IT WAS REPORTED INTRA-OPERATIVELY THAT THE CATHETER EXHIBITED THE VALVE RIPPING OFF. THE CATHETER 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 25371848 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SHEATH SPLIT INTO TWO PIECES NEAR THE HUB OF THE CATHETER. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361227 ↗
• MalfunctionMay 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE LEAD, THE DELIVERY CATHETER BROKE DURING SLITTING. THE DELIVERY CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301378 ↗
• MalfunctionMay 25, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT THE HUB OF THE CATHETER BROKE DURING THE SPLITTING PROCESS. THE LEAD 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 25270275 ↗
• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE WHEN THE PHYSICIAN WAS PREPARING TO SLIT AND WENT THROUGH THE HUB, THE CATHETER BROKE WHERE THE SHAFT MEETS THE HUB. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938449 ↗
• MalfunctionMar 31, 2026Leak/Splash

  IT WAS REPORTED THAT DURING THE CATHETER HAD "NOTICEABLE BLEED BACK FROM THE VALVE DURING USE". THE CATHETER WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741311 ↗
• MalfunctionMar 26, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING IMPLANT DURING SLITTING OF THE CATHETER, THE HUB OR WHITE HANDLE BROKE AWAY FROM THE CATHETER. IT WAS OBSERVED THEREAFTER THAT THE BLUE HEMOSTATIC VALVE HAD DISLODGED FROM THE HUB AND REMAINED ON THE LEAD AS THE HUB/HANDLE BROKE OFF. THE CATHETER 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 24698496 ↗
• MalfunctionMar 26, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT THE SLITTER DISENGAGED DURING SLITTING PAST BASE HUB OF SHEATH. THE SHEATH WAS REMOVED MANUALLY, 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 24698174 ↗