PowerPICC SOLO 3CG C1295118Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741218125), received between Dec 19, 2025 and May 27, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 18, 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.

• MalfunctionMay 27, 2026Product Quality Problem

  IT WAS REPORTED ROUGHNESS OF THE GUIDEWIRE DURING CATHETER PLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300801 ↗
• MalfunctionMar 24, 2026Product Quality Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE DAMAGED ITEMS IN PUNCTURE KIT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681521 ↗
• MalfunctionMar 24, 2026Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE PLACEMENT OF THE MAGNETIC NAVIGATION CATHETER, THERE HAVE BEEN FREQUENT CASES OF CATHETER SCALE DISAPPEARANCE DURING MAINTENANCE, AND THE DISINFECTANTS USED IN CLINICAL PRACTICE ARE IODOPHOR AND CHLORHEXIDINE DISINFECTANTS. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675593 ↗
• MalfunctionMar 24, 2026Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HAIR IN THE PUNCTURE KIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675144 ↗
• MalfunctionMar 23, 2026Material Deformation

  IT WAS REPORTED DURING CATHETER PLACEMENT ON MARCH 6, FRAYING WAS OBSERVED AT THE TIP OF THE MST VASCULAR SHEATH. CLINICALLY, A NEW CATHETER WAS RE-INSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664958 ↗
• MalfunctionDec 19, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED DURING CATHETER PLACEMENT ON (B)(6) IT WAS DISCOVERED THAT THE GUIDEWIRE INSIDE THE MST HAD UNEVEN THICKNESS AND A BARBED TIP AT THE FRONT END. AFTER REPLACING IT WITH A NEW CATHETER, THE SAME ISSUE OCCURRED. ANOTHER BATCH WAS THEN REPLACED FOR CATHETER PLACEMENT. THIS REPORT ADDRESSES BOTH FAULTY DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851494 ↗