PowerPICC® Catheter 9275108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741035692), received between Mar 8, 2017 and Mar 7, 2024 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THEY HAD A PICC BREAK A WEEK AGO AT THE JUNCTION OF THE EXTENSION LEG AND HUB. IT HAD BEEN IN A PATIENT FOR OVER 7 MONTHS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857886 ↗
• MalfunctionMar 30, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  BD MEDICAL SERVICES RECEIVED THE FOLLOWING VIA PHONE CALL: DOCTOR STATES HE JUST PLACED A POWERPICC IN A PATIENT. DOCTOR STATES HE TRIMMED THE CATHETER WHILE THE WIRE WAS STILL IN. WHEN HE REMOVED THE WIRE, IT WAS STILL 50CM IN LENGTH SO NO WIRE WAS LEFT IN THE PATIENT HOWEVER IT APPEARS SOME OF A COATING WAS SHAVED OFF AND IS INSIDE THE CATHETER IN THE PATIENT. DOCTOR IS ASKING FOR THE MATERIAL OF THE COATING OR IF WE KNOW HOW FLOPPY IT IS TO KNOW IF HE WOULD BE ABLE TO REMOVE IT WITH A SNARE. BD MEDICAL SERVICES RESPONDED "INFORMED DOCTOR THE POWERPICC KIT CONTAINS A FLEXURA NITINOL GUIDEWIRE. THE MATERIAL IS NITINOL AND IS NOT COATED. INFORMED DOCTOR UNSURE WHAT "COATING" WOULD HAVE CAME OFF OR IF THE WIRE ITSELF WAS SHAVED OFF. INFORMED DOCTOR WE HAVE NO INFORMATION REGARDING A POTENTIAL SHAVING OF THE GUIDEWIRE IN A PATIENT AND REMOVING IT OR IF HE SHOULD REPLACE THE ENTIRE CATHETER. HOW TO PROCEED IS A CLINICAL DECISION. ADDITIONAL INFORMATION 3/19 DURING FOLLOW UP PHONE CALL WITH CUSTOMER: ¿"FIXED THE PROBLEM: 2 COMMENTS HAS STIFLER WIRING. FORGOT TO PULL THE WIRE BACK BEFORE CUTTING, CUTTING THE OUTER SHEATH OFF OF IT. THE WIRE TOO SHORT TO ACT AS LEAD WIRE. ADVANCED STIFLL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644335 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "IT LOOKS LIKE WE HAVE ANOTHER LEAKING 5FR. AT THE HUB." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306865 ↗
• MalfunctionApr 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE HAD A PICC THAT WAS PLACED LAST NIGHT AND WAS FUNCTIONING FINE AT INSERTION. SHORTLY AFTER IT BEGAN LEAKING AT ONE OF THE LUMENS (PURPLE). THE PICC HAD TO BE REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117960 ↗
• MalfunctionApr 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "PATIENT THAT HAD A LEAKING CATHETER LUMEN. IT HAD TO BE REPLACED AS THE PATIENT WAS BEING DISCHARGED WITH A PICC TO A FACILITY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112712 ↗
• MalfunctionApr 7, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "LEAKING PURPLE HUB OF PICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14045410 ↗
• MalfunctionMar 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED ¿CUSTOMER HAD A LEAKING PICC. LEAKING OCCURRED TODAY WHERE THE NEEDLE FREE CONNECTOR MEETS THE PICC HUB. LEAKAGE IS COMING FROM THE INTERFACE AT CLAVE (NEEDLELESS CONNECTOR) AND PICC HUB ON PURPLE PORT. IT WAS STATED THE CLAVE ( NEEDLELESS CONNECTOR) WAS CHANGED OUT TO ONE FROM A DIFFERENT MANUFACTURER AND ENDED UP WITH THE SAME LEAKAGE. THERE IS NO INDICATION OF PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826096 ↗
• MalfunctionMar 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PICC LEAKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13808956 ↗
• MalfunctionMar 10, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "TWO PICCS THAT HAVE LEAKED WHERE THE HUB MEETS THE EXTENSION SET." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726069 ↗
• MalfunctionMar 10, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "TWO PICCS THAT HAVE LEAKED WHERE THE HUB MEETS THE EXTENSION SET." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726035 ↗
• MalfunctionMar 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "AFTER INSERTING PRODUCT INTO THE PATIENT, THE PURPLE HUB IS LEAKING" NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724246 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING AT THE EXTENSION LEG NEAR HUB. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653768 ↗
• MalfunctionMar 2, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING AT THE EXTENSION LEG NEAR HUB. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653755 ↗
• MalfunctionFeb 16, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "PURPLE LUMEN LEAKING." ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "THE PICC 2 LUMEN WAS PLACED ON THE PATIENT (B)(6) 2022 IN THE AFTERNOON WITHOUT INCIDENT. NO LEAKING WAS NOTED WHEN THE CATHETER WAS FLUSHED, WITH THAT IN MIND USUALLY MY GLOVES ARE WET OR BLOODY SO HARD TO SAY. LATER IN THE EVENING THE CATHETER WAS CONNECTED TO THE INFUSION AND A SHORT WHILE LATER THE PATIENT NOTICED HIS ARM WAS WET. THE PRODUCT WAS RETRACTED THE NEXT MORNING WHEN OUR SERVICE WAS AVAILABLE AND REPLACED WITH A NEW CATHETER IN THE OPPOSITE ARM. THE PATIENT WAS HERE WITH AN INFECTION AND WAS GOING HOME ON MULTIPLE WEEKS OF IV ABX. THE PATIENT WAS AWAKE AND ALERT. NO MANIPULATION CONCERNS WITH THE CATHETER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545927 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED CUSTOMER HAD A PIECE OF STYLE WIRE BREAK ABOUT 3.5 TO 4CM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11181232 ↗
• MalfunctionNov 11, 2020Material Puncture/Hole

  IT WAS REPORTED "WHEN FLUSHING PICC, A HOLE WAS DISCOVERED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822564 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED PATIENT STATED THE PURPLE LUMEN OF HER PICC FELL OFF WHILE SHE WAS AT WORK. PATIENT DENIED PICC GETTING STUCK ON SOMETHING, PULLED OR CUT BY A SHARP OBJECT. PICC WAS SAFE SITED AT THE TIME THIS HAPPENED AS THE PATIENT WAS AT WORK. PT STATED SHE IMMEDIATELY COVERED THE PICC WITH PLASTIC WRAP AND CALLED HER DOCTOR. PATIENTS DOCTOR OFFICE THEN CONTACTED NURSE TO REMOVE HER PICC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214466 ↗
• MalfunctionMar 25, 2020Material Frayed; Defective Device; Material Frayed

  IT WAS REPORTED THAT THE PLACER NOTICED THROUGH X-RAY A PROBLEM WITH THE WIRE- REMOVED PICC SLOWLY AND WAS ABLE TO CLAMP OFF THE DANGLING END OF THE STYLET AND SUCCESSFULLY REMOVED. PATIENT WAS NOT HARMED AND WAS DISCHARGED THE SAME DAY. THE PICC WAS PLACED IN THE RIGHT ARM, NEW PICC PLACED IN OPPOSITE ARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878738 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING AT THE HUB/PICC JUNCTION. THE PICC WAS REMOVED AND A NEW PICC PLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419285 ↗
• MalfunctionApr 11, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN BEDSIDE RN WAS ATTEMPTING TO PREPARE PATIENT TO DRAW LABS, INFUSION PUMP WAS STOPPED. AFTER A FEW MOMENTS, BEDSIDE RN APPROACHED PATIENT AND NOTED BLOOD LEAKING FROM PICC LINE. LEAK WAS NOTED TO BE ABOVE THE PURPLE HUB AT THE TUBING. PICC TEAM RN WAS CONSULTED. PICC TEAM RN CAME TO BEDSIDE, UPON THEIR ASSESSMENT PICC LINE WAS COMPROMISED. AS A RESULT TPN HAD TO BE STOPPED AND PATIENT REQUIRED PERIPHERAL IVS TO CONTINUE IV FLUID REPLACEMENT. PICC LINE NEEDED TO BE REMOVED AND REPLACED. A PIV WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8505467 ↗
• InjuryMar 13, 2019Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH THAT "PT WAS HAVING A PICC LINE PLACED IN HIS RIGHT ARM. AFTER REVIEW OF THE CHEST X-RAY, A PIECE OF THE WIRE WAS LODGED IN RIGHT ARM." NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Information

  MAUDE report 8417809 ↗
• InjuryMar 8, 2017Migration or Expulsion of Device

  WHILE INTRODUCER WAS BEING PLACED AT THE INSERTION SITE, AND OVER THE GUIDEWIRE, THE NURSE ATTEMPTED A TOTAL OF 2 ATTEMPTS TO INSERT THE INTRODUCER. ON THE 3RD ATTEMPT AND THE 2ND NICK TO WIDEN THE INSERTION SITE SHE REALIZED THE GUIDEWIRE HAD MIGRATED INSIDE THE PT. SHE COULD FEEL THE VERY END OF THE GUIDEWIRE AND STOPPED THE PROCEDURE. THIS DEVICE DOES NOT INCLUDE ANY TYPE OF GUIDEWIRE CLIP OF IDENTIFICATION THAT COULD BE PLACED AT THE END OF THE WIRE TO ASSIST WITH MONITORING THE STATUS OF THE GUIDEWIRE WHILE ATTEMPTING TO PLACE THE INTRODUCER, OR PREVENTING IT FROM MIGRATING DURING THIS PROCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 6394704 ↗