PowerPICC HF Catheter 1385118QRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00801741085710), received between Aug 24, 2017 and Jun 16, 2026 — classified as 1 injury, 51 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (28 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Fluid/Blood Leak

  IT WAS REPORTED WHEN REMOVING THE SECURACATH TO REPOSITION THE CATHETER, THEY DISCOVERED THAT THERE WAS A PINPOINT SIZE HOLE IN THE LINE AFFECTING THE WHITE LUMEN. THE GRAY AND RED LUMENS WERE UNAFFECTED WITH EXCELLENT BLOOD RETURN AND NO LEAKAGE WITH FLUSHING. MALFUNCTIONING LINE WAS REPLACED USING OVER-THE-WIRE TECHNIQUE, AND PLACEMENT VERIFIED WITH CXR PER DR'S INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524203 ↗
• MalfunctionJun 16, 2026Device Dislodged or Dislocated

  IT WAS REPORTED PICC LINE INSERTED WITHOUT INCIDENT. PLACEMENT VERIFIED WITH 3CG TECHNOLOGY. INSTRUCTED TO RETRACT LINE 2CM BY DR. DUE TO SOME BRADYCARDIA. CXR OBTAINED TO VERIFY PLACEMENT, AND RN, CONSULTED WITH RADIOLOGIST, DR. LINE WAS APPROPRIATELY TERMINATING IN "SUPERIOR CAVOATRIAL JUNCTION," BUT DR. SAID LINE WOULD BE FINE TO BE RETRACTED 2 CM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia

  MAUDE report 25524196 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN THAT RN FLUSHING PATIENT TRIPLE LUMEN PICC LINE AND NOTICED IT WAS LEAKING. IT SEEMED TO BE LEAKING FROM THE WHITE LUMEN. THE CHG [CHLORHEXIDINE GLUCONATE] PORTION ON THE DRESSING WAS BUBBLING WITH FLUID AND WAS LEAKING DOWN THE DRESSING. THERE WAS POSITIVE BLOOD RETURN ON ALL THREE LUMENS. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444452 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED PICC LINE WAS SPLIT UNDERNEATH THE SECUREMENT DEVICE, CAUSING IT TO LEAK. PICC LINE WAS REPLACED ON OPPOSITE ARM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444428 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  IT WAS REPORTED BY MEDSUN THE GREY LUMEN OF PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE STARTED TO LEAK WHILE FLUSHING IT. THE DEVICE WAS SECURED WITH A SECURACATH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429116 ↗
• MalfunctionJan 29, 2026Fluid/Blood Leak

  IT WAS REPORTED ROUTINE LINE CARE FLUSHES WERE DONE ON A TRIPLE LUMEN PICC. MAINTENANCE FLUIDS WERE INFUSING THROUGH THE RED LUMEN, AND DRESSING WAS CLEAN, DRY, AND INTACT. HOWEVER, WHEN WE FLUSHED THE NS LOCKED WHITE LUMEN, IT LEAKED SALINE FROM BENEATH THE DRESSING. WE REMOVED THE DRESSING TO INVESTIGATE, AND IT SEEMED TO BE LEAKING DIRECTLY BENEATH THE SECURE-A-CATH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208368 ↗
• MalfunctionDec 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC LINE SPLIT ALONG SIDE OF LINE CAUSING 2 OF THE 3 LUMEN TO MALFUNCTION AND SPRAY LIQUID OUT THE SIDE. LINE WAS SECURED WITH SECURE-A-CATH DURING PLACEMENT AND SPLIT OCCURRED INSIDE THIS AREA OF LINE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842496 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PICC TEAM GOT A CALL FROM THE FLOOR NURSE IN ICU STATING THIS PATIENT HAD A TRIPLE LUMEN PICC THAT WAS LEAKING. WE WENT AHEAD AND REPLACED THE PICC IN THE OTHER LINE. LINE IS WORKING WELL WITHOUT COMPLICATIONS CURRENTLY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821724 ↗
• MalfunctionNov 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED WHILE ATTEMPTING TO DILATE THE VEIN DURING THE PICC INSERTION, I WAS UNABLE TO ADVANCE THE DILATOR THROUGH THE SKIN, DESPITE HAVING A 'SKIN NICK'. IT WAS NOTED THAT THE EDGES OF THE DILATOR WERE 'ROUGH' AND A NEW STERILE DILATOR WAS USED TO DILATE THE VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618682 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, VASCULAR ACCESS NURSES REQUESTED TO ASSESS A TRIPLE LUMEN PICC LINE THAT WAS "LEAKING AT THE BIFURCATION." LINE HAD CHG DRESSING INTACT WITH SOME DRAINAGE. SECURE-A-CATH IN PLACE WITH CATHETER OUT 3+CM. GREY LUMEN WAS FLUSHED, AND FLUID WAS NOTED TO BE LEAKING OUT FROM UNDER DRESSING. WHEN DRESSING WAS REMOVED, PICC LINE WAS NOTED TO BE KINKED RIGHT ABOVE THE HUB, BUT 1CM BELOW THE SECURE-A-CATH. WHEN THE LINE WAS STRAIGHTENED IT WAS NOTED TO BE TORN WHERE IT WAS KINKED. CONSULTED PROVIDER TO DISCUSS WHETHER THE PICC NEEDED TO BE REPLACED FOR CONTINUED CENTRAL ACCESS. PROVIDER SAID THAT 2 PIVS WOULD BE SUFFICIENT FOR THE PATIENT. PICC REMOVED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006508 ↗
• MalfunctionSep 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE GREY LUMEN FOR A TRIPLE LUMEN PICC WAS FOUND TO BE LEAKING WHEN FLUSHING. PICC LINE WAS REMOVED AND REPLACED. LEAK WAS EXTERNAL, NO INTERVENTION, NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963488 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDSUN, PATIENTS IN IMAGING RECOVERY UNDERGO A PROCEDURE WHERE THE REGISTERED NURSES AND OTHER CAREGIVERS USE A POWERPICC CATHETER AND IT LEAKS DURING USE. 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 22856353 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE ASSESSMENT OF PICC LINE FOUND THAT ONE OF THE LINES ON A THREE LUMEN PICC WAS LEAKING AROUND THE SECUREMENT DEVICE. FLUSHED ALL THREE LINE, 2 LINES WORKED GREAT. WHITE LINE WAS FOUND TO BE LEAKING. ONCE LINE WAS PULLED. EVALUATED THE LINE MORE IN DETAIL AND FOUND A SPLIT DOWN THE SIDE OF THE PICC WHERE THE SECUREMENT DEVICE, SPLIT WAS ABOUT 1 CM. THERE WAS NOT PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701793 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED IMAGING RECOVERY PICC TEAM AT FACILITY REPORTS THAT PICCS ARE LEAKING WHEN IN USE. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF DEVICES INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669440 ↗
• MalfunctionJul 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC LINE WAS LEAKING BLOOD AND NORMAL SALINE OUT OF THE INSERTION SITE WHEN THE GREY LUMEN WAS FLUSHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22597113 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538672 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538671 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538670 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538669 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THE "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, AND THEY HAD TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (LARGER NICK IN THE SKIN, STRETCH AND PAUSE BEFORE CONTINUING, AND HOLDING MUCH CLOSER TO HUB OF DILATOR). MOST OFTEN, THE DILATOR WOULD JUST BUCKLE AND NOT CREATE THE ROUGH EDGE, BUT SOMETIMES IT CREATED THE ROUGH EDGE MAKING IT UNUSABLE. THE DILATORS ARE UNUSABLE AND HAD TO BE REPLACED MID-PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538667 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT HAD A THREE LUMEN PICC IN RIGHT UPPER ARM. DURING DRESSING CHANGE; LINES WERE CHECKED FOR PATENCY. WHITE LINE WAS FOUND TO BE LEAKING WHERE A SECUREACATH WAS PLACED OVER THE LINE. THE PICC TEAM WAS CALLED TO REPLACE PICC LINE. ONCE THE LINE WAS REPLACED, PICC TEAM EVALUATED THE OLD LINE AND FOUND THE SECUREACATH HAD PINCHED AND CAUSE THE LINE TO SPLIT LENGTHWISE DOWN THE LINE ABOUT AN 1/2 INCH, CAUSING IT TO LEAK. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399030 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC LINE WHITE LUMEN HAD A HOLE IN IT. I FLUSHED OTHER TWO LUMENS WITHOUT ISSUE AND WHITE LUMEN HAD SALINE DRIPPING DOWN OUT THROUGH DRESSING. NO INJURY TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323043 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE LINE WAS A TRIPLE LUMEN PICC THAT WAS LEAKING UNDERNEATH THE DRESSING WHEN THE GRAY LUMEN IS FLUSHED. THE DRESSING WAS INTACT, AND THE LEAKING WAS UNDERNEATH THE DRESSING FELT BY THE PATIENT. THE PATIENT REPORTS NO PAIN. THE LINE WAS ASSESSED, AND THE DRESSING APPEARED TO BE INTACT WITH NO REDNESS OR SWELLING OR ANY OTHER SIGN OF INFECTION. FLUSHED THE THREE LUMENS AND FOUND THE GRAY LUMEN LEAKING UNDERNEATH THE DRESSING. I REMOVED THE DRESSING STERILELY AND FLUSHED THE LINE AGAIN AND IT APPEARED THE LEAKING WAS COMING FROM THE SITE AND NOT FROM THE EXTERNAL LUMEN. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298670 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDSUN WE RECEIVED AN ORDER TO REPLACE A TRIPLE LUMEN PICC LINE FOR THE IV THERAPY TEAM DUE TO LEAKING FROM THE GRAY LUMEN. I EXPLAINED THE PROCEDURE, THE RISKS, AND BENEFITS TO THE PATIENT. HE AGREED TO THE PROCEDURE. PATIENT WAS DRAPED AND CLEANED APPROPRIATELY FOR THE PROCEDURE, AND IT WAS FOUND THAT THE PURPLE AND WHITE LUMEN WERE FLUSHING A DRAWING WELL, BUT THE GRAY ONE WAS LEAKING. AFTER DISCUSSION WITH PA AN OVERWIRE WAS SELECTED TO REPLACE THE PICC LINE. THE PATIENT WAS DRAPED AND CLEANED PER PROTOCOL. THE ORIGINAL PICC WAS REMOVED, AND A WIRE WAS PLACED. I THEN PROCEEDED TO PLACE THE NEW PICC. THE PICC WOULD CROSSOVER THE SUBCLAVIAN, BUT IT WOULD NOT DROP DOWN INTO THE SVC. I CALLED FOR ASSISTANCE. AFTER MULTIPLE ATTEMPTS TO PLACE THE PICC AT BEDSIDE IT WAS DECIDED TO MOVE THE PATIENT TO THE SUITE AND PLACE THE PICC BY FLUOROSCOPY. PATIENT WAS MOVED TO THE SUITE WITH THE PICC LINE STILL PARTIALLY IN. PATIENT WAS DRAPED AND CLEANED PER PROTOCOL IN THE SUITE AGAIN. CLINICIAN WAS ABLE TO PLACE THE PICC LINE INTO THE SVC BY USING FLUOROSCOPY. THE PICC WAS SECURED WITH A SECURECATH AND HCG INFUSED TAGEDERM. PATIENT WAS THEN ASSISTED TO THE WAITING ROOM TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328913 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A TRIPLE LUMEN BARD PICC IN PLACE WITH THE USE OF A SECUREACATH. LOT# REJU3499 PLACED ON (B)(6)2024. THE LINE HAD SPLIT ALONG THE PATH OF THE GRAY LUMEN, WHICH REQUIRED A REPLACEMENT. THE LINE WAS LOCATED ON THE PATIENT'S RIGHT UPPER EXTREMITY, LOWER THIRD OF THE UPPER ARM, WHICH CAUSED ARTICULATION BETWEEN THE HUB OF THE PICC AND THE SECUREACATH. THE REPLACEMENT PICC WAS PLACED IN THE HIGHER THIRD THE LEFT UPPER ARM. RESULTED IN THE NEED FOR TREATMENT AND CAUSED TEMPORARY HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21316683 ↗