PowerPICC® SV Catheter 3173108Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741027529), received between Nov 18, 2016 and Dec 11, 2024 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER OF A FRACTURED PICC OUTSIDE OF THE BODY. THE LINE WAS REMOVED AND REPLACED. NO PATIENT HARM EXCEPT THAT ANOTHER PROCEDURE WAS DONE TO REPLACE THE DAMAGED LINE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905156 ↗
• MalfunctionMay 3, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, "CUSTOMER DESCRIBED A STRANGE BUMPY-LIKE TEXTURE ON THE STYLET. SEEMED TO BE ALMOST PERIODIC BUMPS OR MARKINGS, THAT WERE MORE PROMINENT NEAR THE CATHETER HUB, AND LESS PROMINENT TOWARDS THE DISTAL END." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239367 ↗
• MalfunctionMar 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿PICC LINE HAD TO BE REQUIRED AS IT WAS FOUND TO HAVE A HOLE IN THE SIDE WALL INSIDE THE VESSEL. NO PATIENT IMPACT.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000784 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, ¿PICC LINE HAD TO BE REQUIRED AS IT WAS FOUND TO HAVE A HOLE IN THE SIDE WALL INSIDE THE VESSEL. NO PATIENT IMPACT.¿ NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977611 ↗
• MalfunctionMar 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE LEAKING PICCS. PICCS HAD TO BE REPLACED. NO OTHER INFORMATION WAS PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866400 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC STARTED LEAKING UNDERNEATH HUB. TEAM AGREED THAT THIS WAS A DIFFICULT PATIENT WHO WAS IN CONSTANT MOVEMENT." ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: "PATIENT IS A (B)(6) BOY WITH CARDIAC DISEASE. HE HAS HAD NO RECENT INFECTIOUS DISEASES THAT I CAN FIND. HE RECEIVES CONTINUOUS BIVALIRUDIN THROUGH HIS PICC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509809 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC TEAM HAD A LEAKING, FRACTURED PICC WITH A DIFFICULT PATIENT WHO WAS IN CONSTANT MOVEMENT AND PICC HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506469 ↗
• MalfunctionFeb 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC TEAM HAD A LEAKING, FRACTURED PICC WITH A DIFFICULT PATIENT WHO WAS IN CONSTANT MOVEMENT AND PICC HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506468 ↗
• MalfunctionFeb 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC STARTED LEAKING UNDERNEATH HUB. TEAM AGREED THAT THIS WAS A DIFFICULT PATIENT WHO WAS IN CONSTANT MOVEMENT." ADDITIONAL INFORMATION RECEIVED (B)(6) 2022: "PICC WAS EXCHANGED D/T FRACTURE ON (B)(6) 2022. HE HAS HAD NO RECENT INFECTIOUS DISEASES. HE RECEIVES CONTINUOUS BIVALIRUDIN THROUGH HIS PICC. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483374 ↗
• MalfunctionNov 22, 2021Defective Component; Defective Component

  IT WAS REPORTED "UPON OPENING THE 3 FR SINGLE LUMEN POWERPICC KIT, THE BASE OF THE INTRODUCER NEEDLE WAS NOTED TO NOT BE SEATED WITHIN THE PROTECTIVE COVER." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858443 ↗
• MalfunctionJul 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED "DRESSING WILL NOT PROPERLY ADHERE TO SKIN. COMPLAINT IS FOR ALL PICC KITS WHERE DRESSING HAS MOVED TO A PRIVATE LABEL." NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103280 ↗
• MalfunctionNov 25, 2020Physical Resistance/Sticking

  IT WAS REPORTED BY HEALTH PROFESSIONAL "FRIDAY I WAS IN THE OR ABOUT TO INSERT A 3FR. SINGLE LUMEN POWERPICC SV CATHETER ON A PATIENT. THE VEIN WAS ALREADY ACCESSED, AND THE MICROEZ(TM) MICROINTRODUCER WITH VESSEL DILATOR WERE ALREADY THREADED/ DILATED INTO THE VESSEL, AND CLOSED OFF WITH THE CLEAR END CAP. THE CATHETER WAS FIRST FLUSHED THROUGH WHILE REMAINING IN THE ORIGINAL PACKAGING TO PRIME THE LUMEN AND LINE, BUT NOW WAS REMOVED FROM PACKAGING FOR INSERTION. THE PROBLEM BEGAN, WHEN I WENT TO SLIGHTLY REMOVE THE INTERNAL STIFFENING STYLET (ISS) TO ALLOW FOR TIP TRIMMING PER PATIENT REQUIREMENTS. THE ISS AUTOMATICALLY FELT DIFFERENT, DIFFICULT TO PULL BACK FROM THE LUER-LOCK END OF THE LUMEN. IMMEDIATELY LOOKING TO THE TIP OF THE UNTRIMMED CATHETER, THE ISS WAS SOMEHOW ADHERED TO THE INSIDE OF THE CATHETER LUMEN, ALMOST RESISTANT TO BEING REMOVED- ONLY AT THE UNTRIMMED TIP OF THE CATHETER (APPROX FROM 40CM MARKINGS ALL THE WAY TO THE 45CM MARKINGS; TOTAL LENGTH OF CATHETER BEING 45CM). AS THE CATHETER HAD PREVIOUSLY BEEN FLUSHED/ PRIMED I CANNOT THINK OF ANOTHER REASON FOR THIS TO HAPPEN. THE PATIENT REQUIRED ALMOST THE ENTIRE LENGTH OF THE CATHETER FROM PREVIOUS MEASUREMENTS,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10901084 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED "HOME HEALTH FOUND THE CATHETER LEAKING. THE PATIENT HAD TO BE READMITTED TO THE HOSPITAL, BUT DID NOT REQUIRE ANOTHER PICC. IT IS A 3FR BARD POWER PICC. IT BROKE AT THE VERY END OF THE CATHETER WHERE THE PURPLE EXTENSION TUBING ENTERS THE HARD PURPLE PIECE (THE SAME PLACE THE OTHER POWER PICCS WERE BREAKING). THE LOT NUMBER IS REDU0709."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729629 ↗
• InjuryFeb 28, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT PICC LINE UNABLE TO BE REMOVED AT THE BEDSIDE, PICC PLACED IN THE RIGHT BASILIC VEIN, RESISTANCE MET AFTER 15-20CMS REMOVED, BEDSIDE TEAM ATTEMPTED WARM COMPRESSES, RELAXATION (WALKING, NORMAL ACTIVITIES, ETC), CXR CONFIRMED TIP IN AXILA AND NO KNOTS OR LOOPS IN LINE, PT REFERRED TO IR, NO HARM TO PATIENT, LINE REMAINED PATENT DURING ENTIRE DWELL TIME, NO CATH FLO, ON ANCEF, NO ADDITIONAL LINE NEEDED. LINE SUCCESSFULLY REMOVED IN IR WITH A WIRE INSERTED IN THE SINGLE LUMEN. PT WAS EXPOSED TO FLURO DURING IR REMOVAL. DR. IN SPECIAL PROCEDURES REMOVED LINE WITHOUT COMPLICATION OR SEDATION, PATIENT AND PARENTS EXPRESSED ANXIETY DURING TIMEFRAME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378078 ↗
• MalfunctionFeb 28, 2019Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT PICC LINE UNABLE TO BE REMOVED AT THE BEDSIDE, PICC PLACED IN THE LEFT BASILIC VEIN, RESISTANCE MET AFTER 10CMS REMOVED, BEDSIDE TEAM ATTEMPTED WARM COMPRESSES, RELAXATION (WALKING, NORMAL ACTIVITIES, ETC), CXR CONFIRMED TIP IN AXILA AND NO KNOTS OR LOOPS IN LINE, PT REFERRED TO IR, NO HARM TO PATIENT, LINE REMAINED PATENT DURING ENTIRE DWELL TIME, NO CATH FLO, ON FLAGEL AND SOLUMEDROL, NO ADDITIONAL LINE NEEDED. LINE SUCCESSFULLY REMOVED IN IR ON THE NEXT DAY WITHOUT ANY INTERVENTION, LINE APPEARED TO HAVE RESISTANCE INITIALLY BUT RESOLVED. DR. IN SPECIAL PROCEDURES REMOVED LINE WITHOUT COMPLICATION OR SEDATION. IR REFERRAL UNAVAILABLE UNTIL NEXT DAY ¿ PT SENT BACK HOME WITH LINE PARTIALLY REMOVED AND DRESSED ¿ PT AUTISTIC AND COOPERATIVE WITH BEDSIDE TEAM DURING UNSUCCESSFUL REMOVAL ATTEMPT BUT UNCOOPERATIVE WITH IR¿S SUCCESSFUL REMOVAL, PATIENT AND PARENTS EXPRESSED ANXIETY DURING TIMEFRAME. ACCOUNT NOTED THAT PT REMOVED APPROXIMATELY 5-6 CM OF PICC AT HOME 2 HOUR PRIOR TO SCHEDULED REMOVAL PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378074 ↗
• MalfunctionFeb 27, 2019Physical Resistance/Sticking

  IT WAS REPORTED THAT THE " PICC LINE UNABLE TO BE REMOVED AT THE BEDSIDE, PICC PLACED IN THE RIGHT BASILIC VEIN, RESISTANCE MET AFTER 15-20CMS REMOVED, BEDSIDE TEAM ATTEMPTED WARM COMPRESSES, RELAXATION (WALKING, NORMAL ACTIVITIES, ETC), CXR CONFIRMED TIP IN AXILA AND NO KNOTS OR LOOPS IN LINE, PT REFERRED TO IR, NO HARM TO PATIENT HOWEVER PT COMPLAINED OF CHEST PAIN AFTER INITIAL REMOVAL ATTEMPT, LINE REMAINED PATENT DURING ENTIRE DWELL TIME, NO CATH FLO, ON CLINDAMYCIN, ROCEPHEN, AND VANCOMYCYN, NO ADDITIONAL LINE NEEDED. LINE SUCCESSFULLY REMOVED IN IR WITH A WIRE INSERTED IN THE SINGLE LUMEN. PT WAS EXPOSED TO FLURO DURING IR REMOVAL. DR. IN SPECIAL PROCEDURES REMOVED LINE WITHOUT COMPLICATION OR SEDATION. IR REFERRAL UNAVAILABLE UNTIL NEXT DAY ¿ PT SENT BACK HOME WITH LINE PARTIALLY REMOVED AND DRESSED, PATIENT AND PARENTS EXPRESSED ANXIETY DURING TIMEFRAME. "

  Patient problems: Anxiety; Chest Pain; Radiation Exposure, Unintended

  MAUDE report 8375155 ↗
• MalfunctionAug 22, 2018Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PICC WAS PLACED IN THE CATH LAB ON (B)(6) 2018. IT WAS STATED THAT THE PICC BROKE/TORE EXTERNALLY BY THE HUB ON (B)(6) 2018. THE CATHETER WAS REMOVED AND REPLACED. THE PATIENT HAD TO BE TRANSPORTED TO OPERATING ROOM AND UNDERGO ANESTHESIA IN ORDER TO HAVE THE PICC REPLACED DUE TO HIS COMPLEX CARDIAC CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7807701 ↗
• MalfunctionFeb 24, 2018Break

  IT WAS REPORTED BY THE FACILITY THAT THE PICC WAS PLACED IN THE PATIENT'S LEFT UPPER EXTREMITY AND ON (B)(6) 2017 WAS NOTED TO BE BROKEN BETWEEN THE CATHETER AND THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294463 ↗
• MalfunctionFeb 23, 2018Break

  IT WAS REPORTED BY THE FACILITY THAT THE PICC WAS PLACED IN THE PATIENT'S LEFT UPPER EXTREMITY ON (B)(6) 2017 AND WAS NOTED TO BE BROKEN BETWEEN THE CATHETER AND THE HUB ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7294021 ↗
• MalfunctionJan 23, 2018Break

  THE FACILITY REPORTED TO THE SALES REP THAT THE PATIENT'S LINE BROKE AT HOME. IT WAS STATED THAT THE BREAK SITE WAS AT THE CONNECTION OF THE PURPLE HUB AND TUBING. THE PATIENT HAD THE LINE REMOVED IN THE ED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7212342 ↗
• MalfunctionJan 16, 2018Torn Material

  FACILITY REPORTED TO THE SALES REP THAT THE POWER PICC WAS PLACED ON (B)(6) 2017, AND REPLACED ON (B)(6) 2017, DUE TO A TEAR NEAR THE HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7195370 ↗
• MalfunctionJan 12, 2018Torn Material

  IT WAS REPORTED THAT THE POWER PICC WAS PLACED ON (B)(6) 2017, AND REPLACED ON (B)(6) 2017, DUE TO A TEAR NEAR THE HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7186369 ↗
• MalfunctionNov 16, 2017Break

  IT WAS REPORTED BY THE FACILITY THAT THE POWERPICC WAS PLACED ON (B)(6) 2017. IT WAS REPORTEDLY BROKEN AT THE PURPLE HUB WHERE IT MET THE PURPLE TUBE. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039758 ↗
• MalfunctionNov 18, 2016Difficult to Remove; Sticking; Difficult to Advance; Manufacturing, Packaging or Shipping Problem; Material Distortion

  (B)(6) 2016- PER SALES REPRESENTATIVE, FACILITY STATED THEY "HAVE NOTICED THEIR SUCCESS RATES WITH PLACEMENTS HAS DECREASED SINCE THE PERCEIVED CHANGE IN WIRE (APPROX SINCE LAST FALL). THEY ARE NOTICING THAT THE ¿NEW¿ WIRE HAS TWO TRANSITION AREAS WITHIN THE WIRE, AS OPPOSED TO ONE. THE WIRE IS ESSENTIALLY GETTING HUNG UP DURING PLACEMENTS/CATCHING ON THE VESSEL WALL, MAKING IT HARD TO ADVANCE AND REMOVE. IT IS DESCRIBED AS BEING LESS SMOOTH. ALSO, UPON REMOVAL IT IS NOTICEABLE THAT THE WIRE IS MUCH MORE ¿CROOKED¿ UPON RETRIEVAL. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6113216 ↗