NA C320LBBL45 (UDI 00199150070114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00199150070114), received between Aug 14, 2026 and Sep 23, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.

• MalfunctionSep 23, 2026Break

  It was reported that during the implant procedure "small pieces of the purple coating were seen on the sheath and flaked off upon touch". 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 50866691 ↗
• MalfunctionSep 10, 2026Detachment of Device or Device Component

  It was reported that intraoperatively, during slitting, the luer hub broke off the catheter damaging the lead, causing a kink. The pacing lead 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 50712991 ↗
• MalfunctionSep 1, 2026Detachment of Device or Device Component; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547722 ↗
• MalfunctionAug 26, 2026Detachment of Device or Device Component; Material Integrity Problem

  It was reported that intra-operatively the delivery catheter snapped apart while the physician was slitting, leaving approximately half the catheter in the body. The physician carefully grabbed the catheter with a hemostat and slit it the rest of the way. 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 50451948 ↗
• MalfunctionAug 24, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50406216 ↗
• MalfunctionAug 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257519 ↗