PowerPICC 3CG C1174118Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741218132), received between Feb 19, 2025 and Sep 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Deformation

  It was reported that during catheterization, burrs and splits were found on the puncture sheath, preventing successful puncture. No other information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941804 ↗
• MalfunctionAug 26, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456694 ↗
• MalfunctionMay 12, 2026Material Deformation

  IT WAS REPORTED THAT THE MAGNETIC NAVIGATION CATHETER WAS INSERTED SMOOTHLY, AND THE POSITION WAS NORMAL ON THE POST-INSERTION X-RAY. HOWEVER, AFTER TWO WEEKS OF PLACEMENT, THE PATIENT EXPERIENCED DIFFICULTY IN WITHDRAWING BLOOD. UPON X-RAY CONFIRMATION, IT WAS FOUND THAT THE CATHETER TIP HAD BECOME BENT AND KINKED. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151542 ↗
• MalfunctionMay 1, 2026Material Deformation

  IT WAS REPORTED DURING REPEATED CATHETER ADVANCEMENT, THE CATHETER KINKED DUE TO THE PRESENCE OF A NON-MAGNETIC COATING ON THE GUIDEWIRE, LEAVING A DISTINCT CREASE. CONCERNED ABOUT POTENTIAL DETACHMENT, THE CATHETER WAS REINSERTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25057674 ↗
• MalfunctionApr 1, 2026Material Deformation

  IT WAS REPORTED THAT THE MAGNETIC-GUIDED CATHETER WAS FOUND TO BE KINKED IMMEDIATELY AFTER BEING OPENED, EVEN BEFORE IT WAS USED. THE GUIDEWIRE WAS ALSO KINKED WHEN REMOVED, RENDERING THE CATHETER UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753248 ↗
• MalfunctionFeb 19, 2026Material Frayed; Material Deformation

  IT WAS REPORTED THE INSTRUCTOR HAD DIFFICULTY ADVANCING THE MAGNETIC NAVIGATION CATHETER DURING PLACEMENT. AFTER TWO ATTEMPTS AND RETRIEVAL OF THE STYLET, THE STYLET WAS FOUND NEARLY FRACTURED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388343 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED LESS THAN A MONTH AFTER MAGNETIC NAVIGATION CATHETER PLACEMENT, THE CATHETER COULD NOT BE WITHDRAWN AND EXHIBITED BLOOD REFLUX. ATTEMPTS TO RECANALIZE FAILED, NECESSITATING UNPLANNED CATHETER REMOVAL. POST-REMOVAL INSPECTION REVEALED TWO KINKS IN THE CATHETER APPROXIMATELY 20 CM FROM THE PUNCTURE SITE, WITH DEEP CREASES. THE PATIENT DENIED STRENUOUS PHYSICAL ACTIVITY. THIS CATHETER WAS USED ONLY ONCE FOR CHEMOTHERAPY. THE CATHETERIZATION TEAM REPORTED A SMOOTH PLACEMENT PROCEDURE. CHEST X-RAY REVEALED NO SKELETAL ABNORMALITIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192569 ↗
• MalfunctionJan 15, 2026Fluid/Blood Leak

  IT WAS REPORTED, LEAKAGE AT THE CATHETER INSERTION SITE. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088316 ↗
• MalfunctionDec 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WHITE AND GRAY CONNECTION POINT OF THE PUNCTURE SHEATH EXHIBITED TEARING EVEN WHEN UNUSED. THE SHEATH WAS EXCESSIVELY SOFT, PREVENTING SKIN PENETRATION AND RESULTING IN FAILED PUNCTURES. THIS ISSUE HAS BEEN IDENTIFIED IN A SECOND INSTANCE FROM THE SAME BATCH. IT WAS REPORTED THIS OCCURRED WITH 2 DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937384 ↗
• MalfunctionDec 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT LESS THAN A WEEK AFTER MAGNETIC NAVIGATION CATHETER PLACEMENT, THE CATHETER SEVERELY KINKED, CAUSING BLOCKAGE AND COMPROMISING ITS FUNCTIONALITY. THIS NECESSITATED AN UNPLANNED CATHETER REMOVAL DESPITE THE PATIENT HAVING NO HISTORY OF COUGHING OR STRENUOUS ACTIVITY. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708345 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, LEAKAGE AT 4CM FROM THE END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734401 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER 3CG PICC INSERTED ON MARCH 25. DURING MAINTENANCE TODAY, THE PATIENT FOUND A CRACK ABOUT 5CM FROM THE CATHETER'S INVERTED CONE AND THE CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22019309 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, DURING PICC PLACEMENT, THE CLIENT NOTICED THAT THE EXTENSION TUBING THAT SUPPORTS THE GUIDEWIRE CONNECTION WAS LEAKING AT THE CONNECTION TO THE HEPARIN CAP AND WAS UNABLE TO PRE-FILL THE CATHETER PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416944 ↗