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PowerPICC Catheter 3275355Recalls & reported problems

Bard Access Systems, Inc. · PowerPICC Catheter 5F Dual-Lumen Polyurethane Catheter Radiology Basic Tray (70 cm Nitinol Guidewire) · Class 2 · Implant

All models of PowerPICC Catheter (33)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Bard PowerPICC is a long-term dual-lumen central line placed through a vein in the arm for chemotherapy and other infusions. The 43 reports mostly describe the line leaking or splitting — some cracking while being flushed, some disconnecting at the hub — so the line had to be removed or replaced. Three injuries were reported and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
43
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741027963), received between Dec 4, 2015 and Jun 24, 2025 — classified as 3 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (31 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fluid/Blood Leak31
  • Material Deformation14
  • Crack3
  • Detachment Of Device Component2
  • Improper or Incorrect Procedure or Method2
  • Leak/Splash2
  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions33
  • No Known Impact Or Consequence To Patient6
  • Edema1
  • Exposure to Body Fluids1
  • Local Reaction1
  • Skin Discoloration1
  • Swelling1
  • Thrombus1

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED BY THE CUSTOMER "OUR VAT TEAM WAS CALLED OVER FOR A PICC LINE LEAKING UNDER THE RED PIECE. THERE WAS NO ADVERSE OUTCOME. LINE REMOVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22320008 ↗
  • MalfunctionNov 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE PICC IS LEAKING. NO PATIENT HARM, INJURY, COMPLICATION WAS NOTED BECAUSE OF THE EVENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20635053 ↗
  • MalfunctionSep 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED, SPLIT PICC. PATIENT HAD TO HAVE THEIR PICC REPLACED. PATIENT ON A REGIMEN FOR TUMOR TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20153671 ↗
  • MalfunctionJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED SOLO LINE FRACTURED WHILST FLUSHING THE LINE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19632793 ↗
  • MalfunctionSep 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA MEDWATCH " SUCCESSFULLY PLACED A PICC UNDER X-RAY GUIDANCE. AT THE END OF THE PROCEDURE, THE CATHETER WAS FLUSHED WITH SALINE, AND IT WAS DETERMINED THE CONNECTION AT THE HUB WAS LEAKING. THE CATHETER WAS THEN EXCHANGED FOR A NEW ONE WITHOUT INCIDENT TO THE PATIENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15348879 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240273 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240169 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240152 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240141 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240109 ↗
  • MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED VIA PHONE CALL "POWER PIC CATH KITS LEAKING." NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THIS OCCURRED WITH 6 DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14240105 ↗
  • MalfunctionMar 2, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED "LEAKING AT T-LOCK CONNECTION. PLACED THEN REMOVED IMMEDIATELY WHEN LEAKING NOTED: ALL DURING PROCEDURE NOT AT A SEPARATE TIME."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13654014 ↗
  • MalfunctionFeb 25, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED TWO 5F DL RADIOLOGY PICCS HAVE LEAKED AT THE CASING ON THE PURPLE HUB. IT WAS STATED THE DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE SECOND DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13602317 ↗
  • MalfunctionFeb 25, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED TWO 5F DL RADIOLOGY PICCS HAVE LEAKED AT THE CASING ON THE PURPLE HUB. IT WAS STATED THE DEVICES WERE NOT USED ON PATIENTS. THIS REPORT ADDRESSES THE FIRST DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13602287 ↗
  • MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED 5F DL RADIOLOGY PICC LEAKED AT THE CASING ON THE PURPLE HUB. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13602275 ↗
  • MalfunctionFeb 25, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED 5F DL RADIOLOGY PICC LEAKED AT THE CASING ON THE PURPLE HUB. IT WAS STATED THE DEVICE WAS NOT USED ON A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13601659 ↗
  • MalfunctionFeb 24, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED "LEAKING AT T-LOCK CONNECTION." ADDITIONAL INFORMATION PROVIDED 02/10/2022: PLACED THEN REMOVED IMMEDIATELY WHEN LEAKING NOTED. ALL DURING THE PROCEDURE NOT AT A SEPARATE TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13596264 ↗
  • MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED 5F DL RADIOLOGY PICC LEAKED AT THE CASING ON THE PURPLE HUB. THE DEVICE WAS NOT USED ON A PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13596013 ↗
  • MalfunctionFeb 16, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED A LEAKING PICC. IT WAS STATED THE DEVICE HAD TO BE REPLACED. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SUTURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13545777 ↗
  • MalfunctionFeb 16, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED A LEAKING PICC. IT WAS STATED THE PICC HAD TO BE REPLACED.WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? SUTURED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13545646 ↗
  • MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED "NOTING TWO 5F DL RADIOLOGY PICCS HAVE LEAKED AT THE CASING ON THE PURPLE HUB." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13518489 ↗
  • MalfunctionFeb 11, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED "NOTING TWO 5F DL RADIOLOGY PICCS HAVE LEAKED AT THE CASING ON THE PURPLE HUB." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13518488 ↗
  • MalfunctionFeb 11, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED THE PICC LINE LEAKED AT THE PURPLE HUB. IT WAS STATED THE HUB DID NOT APPEAR CRACKED OR LEAKING AT THE END WHERE THE INJECTION CAP SCREW ON. THE LEAKING CAN BE VISUALIZED FROM THE BODY OF THE PURPLE LUMEN. THIS OCCURRED DURING THE FIRST 24 HOURS OF HAVING THE PICC IN PLACE. ADD INFO RCVD 02/02/2022: PLACEMENT INFO: PLACED ON 1/12 EXCHANGED ON 1/15. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: 3M SECUREMENT DEVICE. WAS THERE PATIENT HARM REPORTED?: NO, EXCEPT PATIENT HAD TO UNDERGO A SECOND PROCEDURE (PICC EXCHANGE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13518226 ↗
  • MalfunctionFeb 11, 2022Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THE PICC LINE LEAKED AT THE PURPLE HUB. IT WAS STATED THE HUB DID NOT APPEAR CRACKED OR LEAKING AT THE END WHERE THE INJECTION CAP SCREW ON. THE LEAKING CAN BE VISUALIZED FROM THE BODY OF THE PURPLE LUMEN. THIS OCCURRED DURING THE FIRST 24 HOURS OF HAVING THE PICC IN PLACE. ADD INFO RCVD 02/02/2022: PLACEMENT INFO: PLACED ON (B)(6). WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: 3M SECUREMENT DEVICE. WAS THERE PATIENT HARM REPORTED?: NO.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13518224 ↗
  • MalfunctionFeb 11, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED THE PICC LINE LEAKED AT THE PURPLE HUB. IT WAS STATED THE HUB DID NOT APPEAR CRACKED OR LEAKING AT THE END WHERE THE INJECTION CAP SCREW ON. THE LEAKING CAN BE VISUALIZED FROM THE BODY OF THE PURPLE LUMEN. PICC WAS LEAKING ON THE TRAY AND WAS NEVER PLACED IN PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13518223 ↗

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Sources and updates

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