PowerPICC® Catheter 3174335Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741027628), received between Jul 11, 2019 and Feb 27, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT PICC HAD A CRACK AND WAS LEAKING AROUND 2CM MARK INTERNALLY. PICC REMOVED AND A NEW ONE PLACED. CATHETER WAS SECURED WITH STATLOCK. PATIENT DIDN'T HAVE ANY SYMPTOMS RELATED TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471653 ↗
• MalfunctionJun 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WE HAVE HAD INCREASED INCIDENCE OF TROUBLE WITH THE PEEL AWAY SHEATH IN THE PICC KIT. IT HAS BEEN BENDING VERY EASILY WHEN TRYING TO INTRODUCE OVER THE WIRE. ALSO LIPPING AT THE SHEATH SO IT'S NOT A SMOOTH TRANSITION FROM THE INTRODUCER TO THE PEEL AWAY. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170566 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT PRESENTS WITH LEAKING OF LINE. WHEN FLUSHING, THE LINE IS LEAKING FROM UNDER THE SOLO VALVE LUER SITE. WHEN PULLED BACK, AIR IS ENTERING THE SYRINGE. PATIENT IS LAID BACK AND CURRENT PICC LINE IS REMOVED. PRESSURE HELD TO SITE UNTIL HOMEOSTASIS IS RECEIVED AND PATIENT LEFT IN THE SUPINE POSITION FOR VASCULAR ASSESSMENT OF THE ARM. ONCE REMOVED, LINE IS VISUALIZED TO HAVE SMALL HOLE APPROXIMATELY 5-6 CM UP LINE WHERE MEDICATION IS DRIPPING FROM, AT THE 6 OR 7 CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031929 ↗
• InjuryMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED; PATIENT WAS IN CLINIC RECEIVING CHEMOTHERAPY TREATMENT. ABOUT HALFWAY THROUGH TREATMENT, LEAKING WAS NOTED FROM THE PICC INSERTION SITE. AREA AROUND THE INSERTION SITE WAS ALSO NOTED TO BE RED/PURPLE. MORE PROXIMAL TO THE PATIENT, TOWARDS HER ARMPIT, AN AREA OF EDEMA WAS NOTED. PATIENT WAS ALSO EXPERIENCING A STINGING SENSATION. ORDERS WERE RECEIVED TO DISCONTINUE THE PICC LINE. ON INSPECTION, A CRACK WAS NOTICED IN THE LINE ITSELF. AS A RESULT, THE PATIENT EXPERIENCED AN EXTRAVASATION. PATIENT NOTED SOME BLEEDING FROM SITE WHEN ONSET. ONCOLOGY STAFF WERE ABLE TO ACCESS THE PICC LINE, WITHDRAW AND FLUSH PRIOR TO CHEMOTHERAPY ADMINISTRATION MEDICATION CONNECTED AND STARTED AS PER INFUSION GUIDELINES. PATIENT HAD PICC INSERTED ON (B)(6) 2025. LINE REMOVED AS PER PROCEDURE, NOTED CRACK 62 MM FROM HUB. REPLACEMENT OF PICC BEING ORGANIZED BY DOCTOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Burning Sensation; Extravasation; Swelling/ Edema

  MAUDE report 21995289 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "IR PLACED 4F SINGLE LUMEN PICC. CLINICIAN REPORTED LEAKING FROM THE END CAP. END CAP WAS REPLACED A FEW TIMES. A NEW SL PICC WAS PLACED. THE SAME THING OCCURRED. THEY THEN TRIED A DIFFERENT END CAP (NEEDLESS CONNECTOR) AND THIS RESOLVED THE ISSUE." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316472 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "IR PLACED 4F SINGLE LUMEN PICC. CLINICIAN REPORTED LEAKING FROM THE END CAP. END CAP WAS REPLACED A FEW TIMES. A NEW SL PICC WAS PLACED. THE SAME THING OCCURRED. THEY THEN TRIED A DIFFERENT END CAP (NEEDLESS CONNECTOR) AND THIS RESOLVED THE ISSUE." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316385 ↗
• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC LEAKED WHERE THE LUER LOCK CONNECTED TO THE CAP. ONCE AGAIN, CAPS HAD BEEN CHANGED WITH SAME RESULT REPEATING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601631 ↗
• MalfunctionFeb 25, 2022Material Frayed; Material Frayed

  IT WAS REPORTED "THE GUIDEWIRE GOT STUCK WITHIN THE NEEDLE, SO THE CLINICIAN WHO WAS PLACING THE LINE REMOVED THE WIRE AND NEEDLE COMPLETELY. THE WIRE THEN FRAYED AFTER IT WAS REMOVED FROM THE NEEDLE OUTSIDE OF THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601065 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC LEAKED AT THE LUER LOCK CONNECTED TO THE CAP. ADDITIONAL INFO. RECEIVED 02/07/2022: "WE JUST EXCHANGED THE DEFECTIVE PICC ON THE PATIENT. THE LEAK WAS REPRODUCED MULTIPLE TIMES WHERE THE LUER LOCK CONNECTED TO THE CAP. ONCE AGAIN, CAPS HAD BEEN CHANGED WITH SAME RESULT REPEATING. ORIGINAL WAS PLACED (B)(6) 2022 AND EXCHANGED (B)(6) 2022. NO HARM OR INJURY WAS SUSTAINED BY THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596295 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE FACILITY HAS "GONE THROUGH 3 CATHETERS AND ALL HAD THE TUBE LEAKING." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518233 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE FACILITY HAS "GONE THROUGH 3 CATHETERS AND ALL HAD THE TUBE LEAKING." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518232 ↗
• MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE FACILITY HAS "GONE THROUGH 3 CATHETERS AND ALL HAD THE TUBE LEAKING." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518229 ↗
• MalfunctionJan 25, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "ON 12/30/21, WE PLACED A 4FR SINGLE LUMEN PICC (REF (B)(4)) (LOT#:REFX0144) ON A PATIENT IN THE MORNING. BEFORE END OF DAY, WE WERE ASKED TO INSPECT THIS CATHETER FOR LEAKAGE. UPON INVESTIGATION, THE CATHETER WAS INDEED LEAKING AT THE LUER LOCK CONNECTION WITH THE POSITIVE PRESSURE CAP. THE CAP WAS CHANGED MULTIPLE TIMES, WITH SUBSEQUENT FLUSHING PRODUCING THE SAME RESULT OF LEAKAGE AT THE LUER LOCK CONNECTION. THE CATHETER WAS EXCHANGED THAT DAY FOR A NEW ONE, DIFFERENT LOT, WITH NO FURTHER ISSUES. NO HARM OR INJURY WAS SUSTAINED BY THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13350600 ↗
• MalfunctionJul 12, 2019Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE WIRE WITHIN THE PROTECTIVE PLASTIC LOOP PACKAGING WAS KINKED, NOT ALLOWING THE WIRE TO BE THREADED THROUGH THE NEEDLE. A SECOND KIT HAD TO BE OPENED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784726 ↗
• MalfunctionJul 11, 2019Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE WIRE WITHIN THE PROTECTIVE PLASTIC LOOP PACKAGING WAS KINKED, NOT ALLOWING THE WIRE TO BE THREADED THROUGH THE NEEDLE. A SECOND KIT HAD TO BE OPENED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8782851 ↗