PowerPICC Catheter 3175118Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741027666), received between Aug 11, 2016 and Dec 18, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED ON 14JAN2026: THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT SUSTAIN ANY SERIOUS OR LASTING INJURY. THE ONLY REPORTED EFFECTS WERE TEMPORARY DISCOMFORT AND INCONVENIENCE DURING THE ATTEMPTED PROCEDURE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND THE EVENT DID NOT RESULT IN HOSPITALIZATION OR EXTENSION OF HOSPITAL STAY.

  Patient problems: Pain

  MAUDE report 23842407 ↗
• MalfunctionNov 5, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT TWO UNITS OF 5 FR SINGLE LUMEN CATHETER ENVELOPES SURROUNDING THE CATHETER BOX WAS NOT SEALED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613176 ↗
• MalfunctionJun 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THE PATIENT WITH PICC CATHETER IMPLANTATION, IMPLANTATION DATE (B)(6) 2023. FAMILY REPORTS LEAKAGE SINCE CATHETER IMPLANTATION. WHEN VISITING, THE CATHETER PRESENTS A LEAK AT THE EDGE, REFLUXING ALL INFUSED MEDICATION. CATHETER DISCARDED AND REPLACED. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 17 JULY 2023: LEAKAGE OCCURRED BETWEEN THE ADAPTER AND THE CATHETER. THERE WAS NO HARM TO THE HEALTHCARE PROFESSIONAL, BUT THERE WAS HARM TO THE PATIENT, SINCE THE MEDICATION WAS NOT COMPLETELY INFUSED. IT WAS NECESSARY TO CHANGE THE CATHETER. THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPY, SINCE THE TEAM OF PROFESSIONALS DECIDED TO ADMINISTER THE CHEMOTHERAPY THROUGH ANOTHER ACCESS. IT WAS NOT REPORTED WHICH DRUG WAS CURRENTLY BEING ADMINISTERED. CATHETER REPLACED BY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17140100 ↗
• MalfunctionJun 14, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED, "THE CATHETER HUB APPEARS TO HAVE CRACKED WHERE THERE IS LEAKAGE OF ADMINISTERED SOLUTIONS. THE CATHETER HAD TO BE CHANGED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131808 ↗
• MalfunctionApr 1, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE POWER PICC CATHETER DID NOT COME WITH THE MARKINGS EVERY 1CM, AT THE HEIGHT OF THE 32CM MARKING THERE IS NO MARKING, REAPPEARING AT THE END OF THE CATHETER. THERE IS NO SAMPLE, DUE TO THE CATHETER BEING INSERTED IN THE PATIENT. ON 03/14/2023: ADDITIONAL INFORMATION RECEIVED. MISSING CATHETER MARKINGS WAS NOTICED PRIOR TO USE. NO PATIENT OR CAREGIVER HARM. THERE WAS NO NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660739 ↗
• MalfunctionJun 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED DURING PASSAGE OF PICC CATHETER, THE INTRODUCER DID NOT PROGRESS. BURRS WERE SEEN. DURING THE PROCEDURE OF PASSING THE PICC CATHETER, THE GUIDE WIRE WAS INTRODUCED INTO THE PATIENT'S VEIN AND WHEN THE DILATOR WAS INTRODUCED IT DID NOT PROGRESS EVEN WITH ALL THE PROCEDURAL TECHNIQUES, WE VISUALIZED BURRS ON THE TIP OF THE DILATOR. DEVICE HAS BEEN DISCARDED DUE TO BIOLOGICAL CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655972 ↗
• MalfunctionSep 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED WHEN PASSING THE PICC CATHETER, THE GUIDE WIRE DID NOT PROGRESS, WHEN REMOVING THE GUIDE WIRE, IT PRESENTED A KNOT AT ITS TIP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12492223 ↗
• MalfunctionOct 2, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN PULLING THE GUIDE TO CUT THE CATHETER, WHITE DIRT WITH FLAKING APPEARANCE WAS IDENTIFIED. THE CATHETER WAS INTRODUCED INTO THE PATIENT WITHOUT COMPLICATIONS, BUT WE WERE CONCERNED IF THESE DIRT REMAINED INSIDE THE CATHETER. THE PROBLEM WAS EVIDENCED DURING THE PASSAGE OF THE POWER PICC CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10620571 ↗
• MalfunctionJul 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE PROCEDURE, IT WAS VERIFIED AT THE MOMENT WHEN THE CATHETER WAS SEROLIZED THAT IT WAS PUNCTURED IN HIS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349394 ↗
• MalfunctionJun 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING IN THE CATHETER EXTENSION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146094 ↗
• MalfunctionDec 7, 2018Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT AFTER 8 MONTHS OF USE, THE PICC CATHETER PRESENTED A FRACTURE / TINY HOLE WITH EXTRAVASATION OF THE SERUM THERAPY NEAR THE INSERTION. IT WAS POSSIBLE TO VISUALIZE DUE TO THE DETACHMENT OF THE DRESSING. BECAUSE OF THIS, X-RAY CONTRAST WAS REQUESTED, CONFIRMING THIS LEAK AND SOON AFTER THE EXAMINATION THE CATHETER WAS REMOVED FROM THE PATIENT.

  Patient problems: Extravasation

  MAUDE report 8142202 ↗
• MalfunctionAug 11, 2016Material Frayed; Physical Resistance

  IT WAS REPORTED THAT DURING THE PROCESS OF INSERTION OF THE PICC, THE GUIDEWIRE WAS INTRODUCED HALF WAY, THEN DID NOT PROGRESS. DURING GUIDEWIRE REMOVAL, ALLEGEDLY IT PRESENTED A LOT OF RESISTANCE AND WHEN IT WAS REMOVED, THIS WAS WITH THE TIP FRAYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5870219 ↗