PowerPICC 1174108D5Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00801741155147), received between Jun 27, 2019 and May 7, 2026 — classified as 4 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A PATIENT CAME IN WITH PRESENT ON ADMISSION PICC. INSERTED ON (B)(6) 2026 ORIGINALLY. VASCULAR ACCESS TEAM CALLED STATING PICC WAS LEAKING, EVALUATED AND CRACK ON SIDE OF LINE/HUB BY WINGS NOTED. PATIENT HAD LINE D/CD. NO PATIENT IMPACT OF DELAY IN CARE. TREATMENT WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111270 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THEY HAVE LEAKAGE/CRACK BELOW THE COLLAR OF THE PICC. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512033 ↗
• MalfunctionJan 27, 2026Product Quality Problem

  IT WAS REPORTED A SAMPLE RETURNED AND DURING EVALUATION IT WAS FOUND THAT THE TIP OF THE STYLET WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192571 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC REMOVED FOR SWELLING, BRUISING, LEAKING AND PAIN AROUND THE INSERTION SITE. AFTER REMOVING IT, WE FOUND A SLIT AT THE 4.5CM MARK. PICC WAS SECURED WITH A SECURACATH AT THE 2CM MARK. HEAT PACKS WERE APPLIED TO THE ARM. A NEW CATHETER WAS INSERTED IN THE INTERNAL JUGULAR BY IR DUE TO LEFT ARM LIB RESTRICTION AND SWELLING TO THE RIGHT ARM FROM THE PREVIOUS PICC. NEW PICC WAS INSERTED IN THE SAME AFTERNOON, SLIGHT DELAY IN TREATMENT BUT NO CLINICALLY SIGNIFICANT.

  Patient problems: Ecchymosis; Pain; Swelling/ Edema

  MAUDE report 23477140 ↗
• MalfunctionJul 11, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED VIA MEDWATCH, PEEL AWAY INTRODUCER DID NOT CLEANLY AND EASILY PEEL AWAY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479670 ↗
• MalfunctionJul 3, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY CUSTOMER THAT MICRO INTRODUCER WAS HARD TO BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401348 ↗
• MalfunctionJun 27, 2025Material Deformation; Material Deformation

  IT WAS REPORTED, PICC PLACED ON 5/30 - LASTED THREE DAYS. COULD NOT FLUSH. NO BLOOD RETURN. PUT IN CATHFLO, DIDN'T WORK. DID AN X-RAY OF ARM AND KINKED IN ARM 5 CM FROM 0 MARK. PATIENT NEEDED X-RAY AND NEW PICC PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349620 ↗
• MalfunctionJun 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PICC INSERTED ON (B)(6); HAD TO BE REMOVED FEW DAYS AFTER. WOULDN'T FLUSH, NO BLOOD RETURN, KINKED AT INSERTION SITE- RIGHT AT 1CM ABOVE THE 0. PATIENT HAD TO GET AN X-RAY. THERE WAS NO SERIOUS INJURY OR ACTUAL ADVERSE EVENT. PATIENTS WERE UPSET OVER HAVING THE PICC REMOVED AND REPLACED DUE TO THE PICC NOT INFUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311953 ↗
• MalfunctionJun 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PICC'S KINKED AND OCCLUDED AND HAVE HAD TO REPLACE WITHIN 5 DAYS. PATIENT HAD ADDITIONAL PROCEDURES (PICC INSERTION) DIRECTLY RELATED TO THE KINKING ISSUE. (NON-FUNCTIONING PICCS WERE REMOVED AND REPLACED WITH NEW PICC). PATIENT HAD ADDITIONAL EXPOSURE TO RADIATION TO INVESTIGATE IF IT WAS A PLACEMENT OR PRODUCT ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310833 ↗
• MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "WE WERE MADE AWARE THAT A PATIENT'S PICC LINE WAS PLACED IN DIFFERENT FACILITY ON 3/7 AND FOUND TO BE FRACTURED JUST TODAY. PICC LINE WAS REMOVED DUE TO SWELLING AND TENDERNESS SURROUNDING PICC SITE DURING INFUSION AND FOUND TO HAVE TWO FRACTURED SITES ON THE CATHETER AT 3CM AND 7CM. PICC IS PLANNED TO BE REPLACED ON (B)(6)."

  Patient problems: Discomfort; Infiltration into Tissue; Swelling/ Edema

  MAUDE report 21881677 ↗
• MalfunctionMar 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFETY DEVICE ON INSERTION NEEDLE FALLS OFF. COURSE OF TREATMENT WAS NOT ALTERED, NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21638592 ↗
• MalfunctionMar 12, 2025Break; Difficult or Delayed Separation; Break; Difficult or Delayed Separation

  IT WAS REPORTED THE BREAK-AWAY TRANSDUCER ON SINGLE LUMEN PICCS WOULD PULL APART BUT HALF OF IT WAS WRAPPED AROUND THE CATHETER AND A PIECE BROKE OFF. LUCKILY, WE WERE ABLE TO RETRIEVE THAT PIECE. NO PATIENT ISSUES OR HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584636 ↗
• MalfunctionMar 12, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THE BREAK-AWAY TRANSDUCER ON SINGLE LUMEN PICCS WAS EXTREMELY HARD TO PULL A PART. THERE WERE NO PATIENT ISSUES OR HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583938 ↗
• MalfunctionMar 5, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT SAFETY DEVICE ON INSERTION NEEDLE FALLS OFF. THE COURSE OF TREATMENT WAS NOT ALTERED, NO HARM TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528961 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WE HAD ONE OF OUR STAFF CALLED TO REPLACE A LINE THAT OUR COMPANY HAD PREVIOUSLY INSERTED 20 DAYS PRIOR DUE TO LEAKING AT THE SITE. WHEN SHE STARTED TROUBLESHOOTING AND CALLED ME WE OPTED TO PULL THE LINE TO INSPECT. SHE FOUND IT HAD A LARGE HOLE AT THE 4.5 CM MARK. HISTORY ON THIS PATIENT: HE HAS BEEN IN AND OUT OF THE NURSING HOME AND CARING FOR THE LINE HIMSELF ALONG WITH HOME HEALTH. HE STATES IT HAD BEGUN TO GET SLUGGISH AND THEN STARTED TO LEAK YESTERDAY AM. I SUSPECT THAT SOMEONE USES EXCESSIVE FORCE TO FLUSH, HOWEVER I CAN NOT PROVE THAT. NO INJURY WAS NOTED TO THE PATIENT. NEGATIVE OUTCOME WAS THAT THE PATIENT HAD TO COME IN FOR A REPLACEMENT PICC DUE TO LEAKING. UNFORTUNATELY, DUE TO HIS EXTENSIVE HISTORY WE WERE NOT ABLE TO GET ANOTHER PICC PLACED AT THE BEDSIDE AND THE PATIENT WAS THEN SENT TO IR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329045 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, CATHETER HAD 2 LUMENS THAT WOULD NOT FLUSH SO WE PULLED AND PLACED THIS LINE AND IT HAD BEGUN TO GET SLUGGISH AND THEN STARTED TO LEAK. STAFF CALLED TO REPLACE THE LINE THAT WAS PREVIOUSLY INSERTED 20 DAYS AGO DUE TO LEAKING AT THE SITE. PULLED THE LINE TO INSPECT AND FOUND A LARGE HOLE AT THE 4.5CM MARK. PATIENT STATES IT HAD BEGUN TO GET SLUGGISH AND THEN STARTED TO LEAK YESTERDAY AM. NO INJURY WAS NOTED TO THE PATIENT. NEGATIVE OUTCOME WAS THAT THE PATIENT HAD TO COME IN FOR A REPLACEMENT PICC DUE TO LEAKING. UNFORTUNATELY, DUE TO HIS EXTENSIVE HISTORY WE WERE NOT ABLE TO GET ANOTHER PICC PLACED AT THE BEDSIDE AND THE PATIENT WAS THEN SENT TO IR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322828 ↗
• MalfunctionJan 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT 12/9/24 HUMERUS X-RAY SHOWS KINK. OSH 4 FR SL POWER PICC NO LOT NUMBER AS OSH. 12/10/24 OWX 5FR TL POWER PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21180999 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC WAS PLACED ON (B)(6) 2023 MEASURING AT 42 CM WITH 1 CM VISIBLE NO SECUREMENT DEVICE WAS USED. ON (B)(6) 2023 THE PICC WAS FOUND TO BE LEAKING AT THE 6CM MARK. PICC WAS REMOVED, NO NEW PICC WAS REQUIRED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120806 ↗
• MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, PICC FRACTURED AND LEAKING AT THE 0CM MARK. TOTAL LENGTH 40CM, EXIT SITE MARKING 3CM, SECURED WITH A SECUREACATH, AND DWELLED FOR 32 DAYS. REINSERTION WAS NOT REQUIRED, PICC REMOVED AND END OF THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120804 ↗
• InjuryJan 9, 2025Break; Break

  IT WAS REPORTED PICC FRACTURED AND LEAKING AT 6-7CM MARK. INSERTED ON (B)(6) 2024 AND DWELLED FOR 33 DAYS, TOTAL LENGTH 47CM AND EXIT SITE MARKING 3CM, SECURED WITH A SECUREACATH. DURING REMOVAL, PICC COMPLETELY FRACTURED AT 6CM MARK; PICC RETAINED IN UPPER ARM AND NEEDED IR TO SURGICALLY REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21120438 ↗
• MalfunctionNov 20, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE PICC NURSES OPENED A SL PICC, THAT HAS A DEFECT. THE OUTER SURFACE HAS A SMALL, RAISED AREA AROUND 37 CM MARK, SORT OF FEELS LIKE DRIED GLUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740533 ↗
• InjuryNov 14, 2024Activation Problem; Activation Problem

  IT WAS REPORTED ON (B)(6) 2024 RN PERFORMED A PICC LINE INSERTION ON A VETERAN. NURSE REPORTED NEEDLE STICK WITH ONE OF THE NEEDLES FROM THE KIT. SHE SHOWED ME THAT WHEN SHE WENT TO LOCK THE NEEDLE, THE LITTLE GREEN SAFETY LOCK CAME OFF AND LEFT THE NEEDLE EXPOSED AND SHE INADVERTENTLY STUCK HERSELF. THE LOCK IS SUPPOSED SLIDE UP THE NEEDLE AND LOCK AT THE END, SO THE SHARP END OF THE NEEDLE IS NOT EXPOSED, BUT IN THIS CASE THE GREEN SAFETY CAME RIGHT OFF. NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20683728 ↗
• MalfunctionApr 11, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED BY THE CUSTOMER "WHEN SEASONED NURSE WAS PLACING A PICC, SHE HAD ONE OF THE ORANGE WINGS BREAK OFF ON THE INTRODUCER INSTEAD OF PEELING AWAY." NO PATIENT HARM WAS DONE, ANOTHER KIT WAS OPENED AND USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087848 ↗
• MalfunctionApr 8, 2024Corroded; Corroded

  IT WAS REPORTED BY THE CUSTOMER "RUSTED CUTTER ON THE PICC LINE TRAY." (B)(6) 2024: IT WAS REPORTED THERE WAS NO IMPACT ON THE PATIENT CARE; THE ISSUE WAS DISCOVERED BEFORE REACHING THE PATIENT. NO IMPACT TO THE HEALTHCARE PROVIDER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060578 ↗
• MalfunctionJan 9, 2024

  UNABLE TO ADVANCE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WIRE DURING INSERTION INTO RIGHT UPPER ARM. NOTED THE NEEDLE WAS "SOLID" AT THE END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475873 ↗