PowerPICC® FT Catheters 1275108FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741034572), received between Dec 15, 2016 and Jun 2, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED WENT TO INSERT A PICC COMPLETELY GOWNED UP NOTICED A LONG BLACK HAIR IN THE KIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366657 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN ISSUE WITH LEAKING FROM A PERFORATION IN ONE OF OUR 5FR DUAL LUMEN POWERPICC CATHETERS. THE LINE HAD TO BE PULLED FROM THE PATIENT AS A RESULT OF THE ISSUE. THEY ALSO USE SECURACATH TO STABILIZE THEIR PICC CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975770 ↗
• MalfunctionDec 13, 2024Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT HAD TO ADJUST THE WHITE PLASTIC PIECE ON THE PICC CLAMP IN ORDER TO MAKE SURE IT COULD STILL CLAMP THE EXTENSION LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930205 ↗
• MalfunctionNov 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT INTRODUCER BENT WHILE BEING INSERTED. MADE IT THROUGH THE SKIN BEFORE ISSUE OCCURRED. THE PATIENT WAS SEDATED IN THE OPERATING ROOM. WHEN THE INTRODUCER FAILED, A NEW KIT HAD TO BE ACQUIRED FROM OUR OFFICE, RESULTING IN THE CHILD BEING SEDATED MUCH LONGER THAN DESIRED. THE PATIENT AS SEDATED A TOTAL OF 45 MINUTES LONGER THAN NECESSARY AS A RESULT OF THE INTRODUCER FAILING. ANOTHER LIMB HAD TO BE PUNCTURED AS A RESULT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633157 ↗
• MalfunctionSep 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED L PICC PLACED (B)(6) FOR DISCHARGE HOME ANTIBIOTICS, RETURNED TO ED NEXT DAY (B)(6) KINK NOTED ON CXR AND OBSERVABLE ¿MEMORY KINK¿ NOTED UPON REMOVAL. CATHETER BECAME "OCCLUDED", "KINK" IN THE CATHETER PREVENTED FLUSHING. WE HAD TO REPLACE THE PICCS IN A FAIRLY SHORT TIMEFRAME. ADDITIONAL INFORMATION RECEIVED ON 11 SEPT, 2024: PATIENT HAD TO RETURN TO THE HOSPITAL (VIA ED DEPARTMENT) AFTER BEING DISCHARGED A DAY PRIOR FOR TROUBLESHOOTING AND REPLACEMENT OF PICC. DELAY OF ANTIBIOTIC ADMINISTRATION. NO PATIENT HARM OR INJURY. LATE ANTIBIOTIC ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20318951 ↗
• MalfunctionAug 2, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT LEAKING AT T-CONNECTOR OF PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443008 ↗
• MalfunctionAug 2, 2023Break; Defective Component; Break; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT LEAKING AT T-CONNECTOR OF PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17440164 ↗
• MalfunctionJul 31, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT DL PICC KITS WHERE THE WIRE COMES OUT OF THE TOP PART (RUBBER PIECE) - ON THE RED PORT AT THE TOP WHERE THE WIRE COMES OUT, WHEN FLUSH SALINE IS LEAKING OUT OF THE TOP. WHEN DRAW BACK OUR BLOOD RETURN, AIR IS COMING INTO OUR SYRINGES. THIS WAS REPORTED TO ME THIS MORNING AND I HAD THEM OPEN A KIT AND SHOW ME. WHEN FLUSH, SALINE JUST LEAKS OUT OF THE TOP OF THAT RUBBER PIECE.

  Patient problems: Insufficient Information

  MAUDE report 17424158 ↗
• MalfunctionJul 31, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER, THAT DL PICC KITS, WHERE THE WIRE COMES OUT OF. THE TOP PART (RUBBER PIECE), ON THE RED PORT AT THE TOP, WHERE THE WIRE COMES OUT. WHEN WE FLUSH SALINE IS LEAKING OUT OF THE TOP. WHEN WE DRAW BACK OUR BLOOD RETURN, AIR IS COMING INTO OUR SYRINGES. THIS WAS REPORTED TO ME, THIS MORNING. AND I HAD THEM OPEN A KIT AND SHOW ME. WHEN YOU FLUSH, SALINE JUST LEAKS OUT OF THE TOP OF THAT RUBBER PIECE.

  Patient problems: Insufficient Information

  MAUDE report 17424060 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LINE WAS PLACED ON 10/16 AND REPORTED TO THE VASCULAR ACCESS NURSE ON 10/24 LINE WAS LEAKING. LINE HAS A HOLE ABOVE THE HUB. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762720 ↗
• MalfunctionDec 1, 2021Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED A FRACTURED PICC STYLET. IT WAS STATED THE STYLET DID NOT BREAK OFF. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911107 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED "PATIENT WAS RESTLESS AND FIGHTING STAFF. LINE PULLED AND SNAPPED OFF CLOSE TO HUB." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910152 ↗
• MalfunctionNov 30, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE RECEIVED SUPPLIES ON FRIDAY, AND OUR VAS NURSES WERE UNPACKING (WAS COMPLETELY SEALED) FOUND FOOD FRAGMENTS." IT WAS REPORTED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE FIRST KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896474 ↗
• MalfunctionNov 30, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE RECEIVED SUPPLIES ON FRIDAY, AND OUR VAS NURSES WERE UNPACKING (WAS COMPLETELY SEALED) FOUND FOOD FRAGMENTS." IT WAS REPORTED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE SECOND KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896461 ↗
• MalfunctionNov 30, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE RECEIVED SUPPLIES ON FRIDAY, AND OUR VAS NURSES WERE UNPACKING (WAS COMPLETELY SEALED) FOUND FOOD FRAGMENTS." IT WAS REPORTED THIS OCCURRED WITH THREE KITS. THIS REPORT ADDRESSES THE THIRD KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896440 ↗
• InjuryNov 4, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "ATTEMPTED PICC PROCEDURE BUT WAS UNABLE TO ADVANCE AND AFTER WITHDRAWING THE PICC THE PLACER REALIZED THAT THE PROXIMAL PIECE OF STYLET BROKE IN THE PATIENT. THE FRAGMENT WAS RETAINED AND IN PATIENT IS IN OBSERVATION FOR NOW. SURGERY AND IR FOLLOWING UP."

  Patient problems: Foreign Body In Patient

  MAUDE report 12751509 ↗
• MalfunctionJun 4, 2021Material Frayed; Material Frayed

  IT WAS REPORTED ATTEMPTED PROCEDURE AND WAS UNABLE TO ADVANCE, WAS PULLED WITHOUT INCIDENT AND WAS NOTED THAT THE MAGNET WIRE BROKE IN MULTIPLE PIECES. DID EVENT OCCUR DURING PLACEMENT, DURING REMOVAL, OR AFTER REMOVAL? DURING INSERTION WAS A NEW DEVICE PLACED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938983 ↗
• MalfunctionFeb 10, 2021Fracture

  IT WAS REPORTED "WE HAD A PICC 5FR DL THAT THE STYLET FRACTURED. IT CAME ALL OUT INTACT BUT BROKE INTO THREE DIFFERENT PIECES." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11311504 ↗
• MalfunctionAug 7, 2020Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  IT WAS REPORTED THAT THE INTER CANNULA OF THE INTRODUCER FELL APART. ADDITIONAL INFORMATION RECEIVED 07/17/2020: 5 FRENCH DUAL LUMEN PICC, INTRODUCER WAS INSERTED SMOOTHLY WHEN THE INNER CANNULA OF THE INTRODUCER WAS UNSCREWED AND REMOVED THE TOP CAME OFF EASILY AND WRITER RETRIEVED THE SHAFT (LONG WHITE PIECE) OUT OF THE GREY SHEATH BEFORE IT ENTERED PATIENTS BLOOD STREAM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378389 ↗
• InjuryApr 2, 2020Material Frayed; Material Frayed

  THE RN PLACING THE DEVICE REPORTED, "ON (B)(6) 2020; I ATTEMPTED TO PLACE A PICC LINE IN THE LEFT BRACHIAL VEIN OF A PATIENT¿S ARM. I WAS UNABLE TO ADVANCE THE WIRE SO I WENT TO PULL THE WIRE OUT, AND IT FELT AS IF THE WIRE GOT STUCK ON THE INTRODUCER NEEDLE, SO I ADVANCED THE WIRE A BIT AND ATTEMPTED TO PULL OUT THE WIRE AND INTRODUCER NEEDLE TOGETHER AND IT WOULD NOT COME OUT. THEN I REMOVED THE INTRODUCER NEEDLE AND PULLED GENTLY BACK ON THE WIRE AND AS I WAS REMOVING THE WIRE, THE WIRE WAS UNCOILING AND ENDED UP SNAPPING AND LODGING THE TIP PORTION OF THE WIRE INTO THE PATIENT¿S ARM. I NOTIFIED THE PATIENT IMMEDIATELY THAT THERE WAS A CHANCE THERE WAS A PIECE OF WIRE IN HER ARM AND WE WOULD POSSIBLY NEED TO RUN SOME TESTS TO SEE IF THAT WAS TRULY THERE. I NOTIFIED THE DOCTOR WHO WAS THE PHYSICIAN FOR THE DAY AND HE ORDERED A CTA OF THE LUE. UPON CTA COMPLETION THE WIRE WAS DEFINITELY SEEN. I FILLED OUT AN INCIDENT REPORT THAT DAY. EVENTUALLY SURGERY WAS PERFORMED ON PATIENT AND THE WIRE WAS REMOVED FROM HER ARM."

  Patient problems: Foreign Body In Patient

  MAUDE report 9916480 ↗
• MalfunctionMar 22, 2019Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT THE PICC SENSOR WIRE WAS OBSERVED TO BE "BADLY FRACTURED", 1.5 INCH OF THE SENSOR WIRE WAS SHARPLY BENT AND WITH A LITTLE TUG IT BROKE COMPLETELY. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8445750 ↗
• MalfunctionFeb 12, 2019Material Puncture/Hole

  IT WAS REPORTED THAT THE REGISTERED NURSE WENT TO TEAR AWAY THE INTRODUCER AND THERE WAS A SECTION THAT DID NOT TEAR AWAY. IT WAS STATED THAT THE RN TRIED TO CUT THE PLASTIC W A SCALPEL AND ENDED UP POKING A HOLE IN THE CATHETER. A NEW CATHETER WAS PLACED OVER THE WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332359 ↗
• MalfunctionJan 11, 2019Fluid/Blood Leak; Priming Problem

  IT WAS REPORTED THAT WHEN THE RN STARTED PRIMING THE LINE, HE NOTICED THAT ALL WAS SQUIRTING ALL OVER. IT WAS STATED HE TRIMMED THE CATHETER AND NOTED THE LINE WAS INCONSISTENTLY DIVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8242143 ↗
• MalfunctionSep 7, 2018Break

  IT WAS REPORTED THAT THE PICC WAS PLACED ON (B)(6) 2018 AROUND 11:30AM. THE NURSE RAN INTO IMMEDIATE DIFFICULTY WHEN THREADING BY THE AXILLA. THE NURSE FELT A BLOCK, SO HE PUSHED THROUGH AND THE CATHETER WAS ABLE TO GET THROUGH THE CURVATURE. HE CONFIRMED PEAK P-WAVE AND THEN RETRACTED THE GUIDEWIRE AND IT FELT "SHORT" EVEN THOUGH 3CG SHOWED THE PICC WAS IN THE RIGHT PLACE. HE THEN DECIDED TO PULL THE ENTIRE GUIDEWIRE OUT OF PATIENT AND THAT¿S WHEN HE NOTICED IT TRULY WAS TOO SHORT IN LENGTH AND PART OF THE GUIDEWIRE SHEARED OFF. HE THEN REMOVED THE ENTIRE PICC LINE AND FLUSHED BOTH LUMENS WITH SALINE AND DISCOVERED THE SHEARED OFF MAGNETIC TIP. THE MAGNETIC TIP HAD RESIDED WITHIN THE PICC LINE, IT WAS NOT LEFT IN THE PATIENT. HE THEN OPENED A NEW 4FR SL KIT AND USED THAT GUIDEWIRE TO REINSERT PICC LINE. 09/11/2018 PER MEDWATCH: A 5 FR D/L PICC 3CG INSERTED, WHEN NOTED GUIDEWIRE TIP ABOUT 3CM SHEARED OFF. THE TIP THAT SHEARED OFF REMAINED INSIDE THE PICC LINE. PICC LINE WAS REMOVED, FLUSHED WITH SALINE AND THE 3CM GUIDEWIRE TIP CAME OUT OF THE PICC LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855770 ↗
• MalfunctionJun 26, 2018Fracture

  FACILITY REPORTED THAT THEY HAD TO REPLACE A DL FT PICC DUE TO THE PICC FRACTURING AT THE JUNCTION BETWEEN THE PICC AND WHERE THE WINGS CONNECT TO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7638529 ↗