PowerPICC 1174108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741154935), received between Dec 13, 2018 and Dec 10, 2025 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Mar 11, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE IS AN OILY SUBSTANCE ON THE PROBE COVER IN THE PICC TRAY. NO PATIENT IMPACT. KIT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769001 ↗
• MalfunctionNov 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHILE ACCESSING PATIENT FOR PICC LINE, GOT INTO VEIN WITH GREEN ACCESS NEEDLE, THREAD GUIDEWIRE AND REMOVED ACCESS NEEDLE OVER THE WIRE, ATTEMPTED TO SAFETY GREEN ACCESS NEEDLE AND THE GREEN SAFETY FLEW OFF LEAVING US UNABLE TO SAFETY THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476037 ↗
• MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ONCE THE PICC LINED WAS PULLED, THERE WAS A CRACK IN IT AT ABOUT THE 4-5CM MARK. PATIENT WAS READMITTED TO HOSPITAL DUE TO PICC MALFUNCTION. HE REPORTED ¿LEAKING¿ FROM THE INSERTION SITE WHEN USING FLUSH, SWELLING OF THE ARM WHEN RECEIVING ANTIBIOTIC INFUSIONS. HE HAD AN ULTRASOUND PERFORMED TO CHECK FOR BLOOD CLOTS WHICH WAS NEGATIVE. A SECOND LINE WAS PLACED TO COMPLETE HIS INFUSION.

  Patient problems: Infiltration into Tissue; Swelling/ Edema

  MAUDE report 22527296 ↗
• MalfunctionAug 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT, "VAST WAS NOT ABLE TO FLUSH THE LINE. PICC WAS PLACED ON (B)(6) 2024 BY VAST. ON (B)(6), VAST WAS CONTACTED BY HEALTH PROFESSIONAL WITH HOME HEALTH ABOUT THE LINE BEING OCCLUDED EVEN AFTER CATHFLO WAS DONE. THE PATIENT CAME IN ON (B)(6) WITH HIS DAUGHTER TO HAVE IT DE CLOTTED OR REPLACED. THE LINE HAD A SECURACATH SECUREMENT DEVICE THAT WAS PLACED AT THE TIME THE LINE WAS PLACED. VAST WAS NOT ABLE TO FLUSH THE LINE WHEN HE ARRIVED. THE PATIENT REPORTED THAT THE LINE WAS POSITIONAL FOR THE LAST FEW DAYS AND HE HAD TO KEEP HIS ARM STRAIGHT AND TURN THE ARM TOWARD HIS BODY AS MUCH AS HE COULD TO GET THE LINE TO FLUSH. HE DID REPORT THAT THE LINE WOULD RETURN BLOOD BUT NOT FLUSH. VAST COULD NOT GET BLOOD RETURN OR FLUSHING WHEN HE CAME IN. VAST REMOVED THE LID FROM THE SECURACATH AND THE PICC WAS NOT LAYING IN THE CHANNEL WHERE IT SHOULD BE BUT LAYING ON TOP OF THE BLUE COLUMNS MEANT TO HOLD THE LINE IN PLACE. THE PICC WAS FLATTENED FROM 0 TO 1 CM WHERE THE DEVICE WAS AT AND THERE WAS A SLIGHT KINK JUST PROXIMAL TO THE SECURACATH AT THE 1 CM MARK. VAST NURSE PULLED THE LINE OUT BY 1 CM AND THE PICC FLUSHED AND RETURNED BLOOD EASILY. THE SECURACATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20093196 ↗
• MalfunctionMay 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT NURSE WAS CALLED TO EVALUATE A LEAKING PICC. THE PICC HAD BEEN PULLED OUT A FEW DAYS BEFORE ABOUT 6CM AND LEFT OUT. THE PATIENT WAS TRYING TO PULL IT OUT FURTHER BUT IT HAD A SECUREACATH SECUREMENT DEVICE ON IT SO IT STAYED. WHEN SHE ARRIVED AND FLUSHED IT, IT SQUIRTED OUT SALINE. PICC HAD TO BE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19337408 ↗
• MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "A PICC WAS LEAKING WHEN FLUSHED. AFTER ASSESSMENT FROM OUR NURSE, SHE WAS NOT ABLE TO FIX THE ISSUE SO SHE PULLED THIS LINE. ONCE THE LINE WAS PULLED SHE NOTED A "SLIT" AT APPROXIMATELY JUST PAST THE 10CM SECTION OF THE LINE. THE LINE WAS PLACE BY OUR STAFF APPROXIMATELY 6 WEEKS PRIOR TO THE ISSUE AND HAD BEEN RECEIVING OUTPATIENT IV HOME THERAPY" ADDITIONAL INFORMATION RECEIVED 4/9/2024: IT WAS REPORTED BY THE CUSTOMER "PATIENT HAD PICC PLACED WITHOUT INCIDENT PER OUR COMPANY WITH 3CG CONFIRMATION. UNSURE OF THE EVENTS THAT TOOK PLACE AT HOME IF THEY [PATIENT] USED EXCESSIVE FORCE ETC. TO PUSH MEDS OR FLUSH. SHE REPLACED THE LINE IN THE OPPOSITE ARM. NO LONG LASTING COMPLICATIONS NOTED TO THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235015 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PATIENT NOTICED LEAKING FROM THE CONNECTION BETWEEN THE END OF THE LUMEN AND NEEDLESS CONNECTOR. WE PLACED THE PICC WITHOUT ISSUE, BUT SHORTLY AFTER, THE PATIENT NOTICED LEAKING FROM THE CONNECTION BETWEEN THE END OF THE LUMEN AND NEEDLESS CONNECTOR. WE ENDED UP CATCHING IT VERY EARLY AND WERE ABLE TO EXCHANGE THE PICC. HOWEVER, PATIENT WAS SCHEDULED FOR CHEMO LATER IN THE DAY. ONCE WE REMOVED THE PICC, IT WAS CLEAR THAT WE WERE UNABLE TO GET A SEALED CONNECTION BETWEEN THE NEEDLESS CONNECTOR AND END OF THE RED LUMEN. WE TRIED MULTIPLE NEEDLESS CONNECTORS, ALL WITH THE SAME OUTCOME. FLUID WOULD SLOWLY LEAK AROUND THE RED LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226087 ↗
• MalfunctionJun 13, 2023Material Frayed; Material Frayed

  IT WAS REPORTED, "WE WERE PLACING A PICC AND WHEN WE WENT TO PUSH THE WIRE BACK THROUGH THE PICC AFTER CUTTING THE PICC TO MEASURED LENGTH, IT WAS NOTICED THAT THE PICC WIRE (2 INCHES FROM THE END) WAS BROKEN AND HANGING ON BY A THREAD. THE WIRE EVENTUALLY FULLY SNAPPED AND BROKE OFF WITH NURSE TOUCHING IT." ADDITIONAL INFORMATION RECEIVED 06/02/2023: "THE INTERNAL PICC WIRE WAS BROKEN AND HINGED PRIOR TO INSERTING PICC LINE SO NO PIECES WERE RETAINED IN THE PATIENT OR NEEDING RETRIEVAL.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122283 ↗
• MalfunctionJun 8, 2023Material Discolored; Defective Component; Material Discolored; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT STERILE GOWN IN KIT HAS STAIN ON IT. ADDITIONAL INFO RECEIVED ON 24MAY2023: IT WAS REPORTED BY THE CUSTOMER "THE STAIN WAS NOTICED UPON UNWRAPPING STERILE PACKAGING AND DONNING GOWN. THE PACKAGE WAS INTACT PRIOR TO OPENING. STERILE WRAPPING WAS INTACT. WE ARE UNABLE TO IDENTIFY THE STAIN- DOES HAVE A "SNAG" NEAR THE STAIN." IT WAS REPORTED THIS OCCURRED WITH TWO GOWNS. THIS REPORT ADDRESSES THE FIRST GOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090386 ↗
• MalfunctionJun 8, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT STERILE GOWN IN KIT HAS STAIN ON IT. ADDITIONAL INFO RECEIVED ON 24MAY2023: IT WAS REPORTED BY THE CUSTOMER "THE STAIN WAS NOTICED UPON UNWRAPPING STERILE PACKAGING AND DONNING GOWN. THE PACKAGE WAS INTACT PRIOR TO OPENING. STERILE WRAPPING WAS INTACT. WE ARE UNABLE TO IDENTIFY THE STAIN- DOES HAVE A "SNAG" NEAR THE STAIN." IT WAS REPORTED THIS OCCURRED WITH TWO GOWNS. THIS REPORT ADDRESSES THE SECOND GOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090169 ↗
• MalfunctionMar 24, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER, "REGARDING PICC INSERTION KITS THAT RECENTLY HAVE TRANSITIONED TO NEWER STYLE KITS WITH A DIFFERENT EXTENSION SET WITH THE WIRE EXTENDING THROUGH THE PORT. THE NEW STYLE T-PORT HAS A MORE CONCAVE STYLE IN WHICH THE WIRE FEEDS THROUGH.  THE INSERTION OF SINGLE LUMEN LOT REGX3255 AIR ENTERED THE CATHETER AT THE T-PORT INTO THE PICC AND PULLED BACK AIR AS THEY RETRACTED THE T-PORT SYRINGE. THE PICC WAS IMMEDIATELY REMOVED OR CLAMPED AND MANAGED WITHOUT PATIENT HARM. THE SL PICC WAS ABORTED, AND A NEW KIT USED TO PLACE THE LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16613901 ↗
• MalfunctionFeb 23, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "WHEN PLACING THE PROBE COVER ON THE PROBE, THERE IS A SMALL HOLE THAT GEL COMES THROUGH WHEN PLACING THE RUBBER BANDS AROUND THE PROBE. THIS HAS HAPPENED FOUR TIMES NOW. HAD TO REPLACE PROVE COVER AND STERILE GLOVES BEFORE MOVING FORWARD WITH PICC" THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433519 ↗
• MalfunctionFeb 23, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "WHEN PLACING THE PROBE COVER ON THE PROBE, THERE IS A SMALL HOLE THAT GEL COMES THROUGH WHEN PLACING THE RUBBER BANDS AROUND THE PROBE. THIS HAS HAPPENED FOUR TIMES NOW. HAD TO REPLACE PROVE COVER AND STERILE GLOVES BEFORE MOVING FORWARD WITH PICC" THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433068 ↗
• MalfunctionFeb 23, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "WHEN PLACING THE PROBE COVER ON THE PROBE, THERE IS A SMALL HOLE THAT GEL COMES THROUGH WHEN PLACING THE RUBBER BANDS AROUND THE PROBE. THIS HAS HAPPENED FOUR TIMES NOW. HAD TO REPLACE PROVE COVER AND STERILE GLOVES BEFORE MOVING FORWARD WITH PICC" THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433045 ↗
• MalfunctionFeb 23, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT "WHEN PLACING THE PROBE COVER ON THE PROBE, THERE IS A SMALL HOLE THAT GEL COMES THROUGH WHEN PLACING THE RUBBER BANDS AROUND THE PROBE. THIS HAS HAPPENED FOUR TIMES NOW. HAD TO REPLACE PROVE COVER AND STERILE GLOVES BEFORE MOVING FORWARD WITH PICC" THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433044 ↗
• MalfunctionJan 17, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "MULTIPLE INSERTERS HAVE COMPLAINED THAT THE 4.5FR MICROINTRODUCER UNABLE TO GET THROUGH SKIN OVER WIRE WITHOUT CUTTING SKIN WITH SCALPEL. NOTICEABLE WEAKER AND PRONE TO BENDING WHICH CAN POTENTIALLY BEND WIRE INSIDE THE VEIN/BODY. INTRODUCER SHEATH PEELS AWAY FROM INTRODUCER TO EASIER." A SPECIFIC NUMBER OF AFFECTED DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16187132 ↗
• MalfunctionApr 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PATIENT'S PICC WAS INSERTED ON (B)(6) 2022 BUT PATIENT WAS SENT TO ANOTHER HOSPITAL FOR A WHILE. RECENTLY, PATIENT'S NURSE NOTICED THE PICC WAS LEAKING NEAR THE EXTENSION LEG CONNECTION HUB. NO PATIENT HARM. THE CRACK WAS ON THE EXTENSION LEG, UNDERNEATH THE GRIP WHERE THE NEEDLESS CONNECTOR IS CHANGED. LEAK OCCURRED DURING FLUSHING. PICC WAS REMOVED FROM PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14179907 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "HOLE IN THE TUBING AT 8CM MARK." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591838 ↗
• MalfunctionApr 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CUSTOMER PLACED PICC LINE IN PATIENT AND WAS CALLED BACK IN BECAUSE OF LEAKING, UPON INSPECTION THERE WAS A PIN-SIZED WHOLE IN THE EXTENSION LEG NEAR THE CLAMP OF THE PICC." ADDITIONAL INFORMATION RECEIVED (B)(6) 2021: IT WAS REPORTED BARD 4FR SINGLE LUMEN POWER PICC'S WERE USED WITH PINHOLE LEAK ON THE TUBE WHERE THE CLAMP IS LOCATED, DISCOVERED 12 HOURS AFTER LINE INSERTION. PATIENT RECEIVING LONG TERM ANTIBIOTIC THERAPY. NO HARM WAS DONE. THE LINE WAS EXCHANGED USING THE OVER THE WIRE TECHNIQUE WITHOUT INCIDENT. STATLOCK USED TO STABILIZE THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746524 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CUSTOMER PLACED PICC LINE IN PATIENT AND WAS CALLED BACK IN BECAUSE OF LEAKING, UPON INSPECTION THERE WAS A PIN-SIZED WHOLE IN THE EXTENSION LEG NEAR THE CLAMP OF THE PICC." ADDITIONAL INFORMATION RECEIVED 04/06/2021: IT WAS REPORTED BARD 4FR SINGLE LUMEN POWER PICC'S WERE USED WITH PINHOLE LEAK ON THE TUBE WHERE THE CLAMP IS LOCATED, DISCOVERED 12 HOURS AFTER LINE INSERTION. PATIENT RECEIVING LONG TERM ANTIBIOTIC THERAPY. NO HARM WAS DONE. THE LINE WAS EXCHANGED USING THE OVER THE WIRE TECHNIQUE WITHOUT INCIDENT. STATLOCK USED TO STABILIZE THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713526 ↗
• MalfunctionMar 12, 2021Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THE EKG PAD LOOKED TO BE SOILED UPON OPENING THE PACK FROM THE STERILE PICC KIT. THE DEVICE WAS NOT USED ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474662 ↗
• MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "PICC LINE DIFFICULT TO FLUSH, CAME TO ED FOR EVALUATION AND PICC REQUIRED REMOVAL. AT TIME OF REMOVAL IT WAS NOTED THERE WAS A SPLICE IN THE CATHETER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583873 ↗
• MalfunctionApr 25, 2019Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DIFFICULT TIME ADVANCING THE PICC LINES INTO APPROPRIATE POSITION AND WERE MEETING RESISTANCE IN AREAS OF THE VEIN. AFTER THE PROCEDURES WERE DONE WE HAD FOUND THE STYLET WIRE INSIDE THE PICC CATHETERS WAS BENT AT ALMOST A 90 DEGREE ANGLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552150 ↗
• MalfunctionDec 13, 2018Break

  IT WAS REPORTED THAT THE INTRODUCER NEEDLE WAS BROKEN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161483 ↗