NA C320LBBS45 (UDI 00199150070138)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00199150070138), received between May 15, 2026 and Sep 30, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Accessory Incompatible; Break

  It was reported that during implant when trying to engage the slitter the catheter hub broke and the lead dislodged. The catheter was not used and replaced with the lead successfully being implanted afterwards. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944281 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  It was reported that intraoperative the guiding catheter broke between the hub and the main body of the catheter when slitting. The pacing lead was successfully implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865406 ↗
• MalfunctionSep 18, 2026Leak/Splash; Material Integrity Problem

  It was reported that during the implant procedure the catheter was leaking and it was noted that the blue valve had fallen 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 50814389 ↗
• MalfunctionSep 15, 2026Break

  It was reported that during the implant procedure, the catheter was performing as expected during the delivery and deployment of the lead. When the physician slit the catheter, it snapped in half but the remnants were extracted and a hemostat was used to continue to slit the sheath. The lead was stable and was successfully implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767790 ↗
• MalfunctionAug 27, 2026Break

  It was reported that during the implant procedure the catheter fractured perpendicular to the slitting direction. 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 50476212 ↗
• MalfunctionAug 10, 2026Material Integrity Problem

  It was reported that intra operatively during the placement of the lead, When slitting the sheath, the catheter snapped just past the hub. The catheter was then gripped with artery forceps and slitting continued successfully with no movement of the lead. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190646 ↗
• MalfunctionAug 6, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160939 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158301 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  It was reported that during the implant procedure of the pacing lead, the slitter passed through the catheter hub to the main body, the catheter hub completely detached from the main body, leaving the lead and main catheter body still engaged with the slitter. Physician was able to use forceps to continue slitting the catheter without dislodging the lead nor causing any other complications. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156785 ↗
• MalfunctionJul 28, 2026Detachment of Device or Device Component; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060001 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT INTRA-OPERATIVELY CONTRAST INJECTION WAS PERFORMED VIA THE DELIVERY CATHETER INJECTION PORT. DURING THE INJECTION, CONTRAST MEDIUM LEAKED FROM THE CATHETER AND A LARGE TEAR WAS NOTED IN THE VALVE. THE CATHETER 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 25182639 ↗