PowerPICC Catheter 3276135Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741028007), received between Oct 25, 2016 and May 13, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Misconnection; Misconnection

  IT WAS REPORTED IR WAS USING THE STATLOCK PICC FROM THE PICC IR TRAY TO SECURE PICC. HOWEVER, ONE OF THE STATLOCK PICC RETAINER DOOR COULD NOT CLOSE WHILE APPLYING STATLOCK TO PICC. IR CONTINUE TO USE THIS DEFECTIVE STATLOCK PICC BY ENHANCING THE SECUREMENT WITH STERILE STRIP AND TRANSPARENT DRESSING. CATHLAB NURSE MANAGER TO REPLACE DEFECTIVE STATLOCK PICC WITH NEW ONES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009103 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AT THE BEGINNING OF PICC INSERTION PROCEDURE, INTERVENTIONAL RADIOLOGIST AND SCRUB NURSE CHECK THE PATENCY OF PICC SET BY FLUSHING ALL DEVICES AND TOOLS. POWERPICC 6F CATHETER WAS FOUND LEAKED WHILE FLUSHING. SCRUB NURSE SHOWED TO INTERVENTIONAL RADIOLOGIST OF THE LEAKING PICC CATHETER. INTERVENTIONAL RADIOLOGIST INSTRUCTED TO OPEN A NEW PICC 6F SET TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035766 ↗
• MalfunctionSep 28, 2023Material Frayed; Material Twisted/Bent; Material Frayed; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING PROCEDURE, NOTICED THAT THE PICC GUIDEWIRE CURLED UP UPON CHECKING THRU FLUROSCOPY SCAN AS PATIENT WAS COMPLAINING OF PAIN. TRIED TO TAKE OUT THE GUIDEWIRE BUT IT WAS STUCK AT THE PUNCTURE NEEDLE. HAVE TO TAKE OUT GUIDEWIRE TOGETHER WITH PUNCTURE NEEDLE. CHANGED OR OPENED ANOTHER PICC SET. NO PROBLEM WITH THE NEW PICC SET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 17839789 ↗
• MalfunctionSep 19, 2023Defective Component; Defective Component

  IT WAS REPORTED ONE OF THE WING OF THE PICC DROPPED OFF AFTER 4 WEEKS OF INSERTION. DOCTOR HAD TO SUTURE THE PICC ON THE PATIENT INSTEAD OF USING STATLOCK. THE PICC WAS INSERTED IN THE PATIENT FOR ABOUT 4 WEEKS. ADDITIONAL INFORMATION RECEIVED 6/13/2023: PICC WAS REMOVED AFTER 3 ¿ 4 DAYS AFTER THE WING BROKEN. 09/01/2023- IT WAS FOUND DURING INVESTIGATION THAT A COMPLETE BREAK AND SEPARATION OF THE SUTURE WING WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17773744 ↗
• MalfunctionAug 31, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT UPON OPENING, GUIDEWIRE BENT AT 8 DIFFERENT AREAS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662137 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, PICC LINE FAULTY. LINE LEAKAGE. (B)(6) 2023: PICC WAS CHANGED OUT AFTER THE LEAKAGE WAS OBSERVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17041242 ↗
• MalfunctionMay 2, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED HAIR FOUND IN THE PACKAGING OF THE ITEM. IT WAS DISCOVERED FOUND BEFORE USE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856016 ↗
• MalfunctionDec 29, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT PEEL-AWAY SHEATH IS "FAULTY". PATIENT WAS REPORTED AS FINE AFTER EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071068 ↗
• MalfunctionDec 13, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT "RESIDENT NURSE GOES UP TO THE WARD TO CHECK ON PATIENT AND IT WAS BROUGHT TO HIS ATTENTION THAT ONE OF THE PATIENT PICC LINE CLAMP IS 'CRACKED' ¿ ONLY ON ONE SIDE OF THE AFFECTED CLAMP. BECAUSE OF THIS CRACK THEY ARE NOT ABLE TO CLAMP THE PICC PROPERLY. THE TEAM HAS NOT DECIDED WHAT TO DO YET ¿ TO LEAVE THE PICC AS IT IS SINCE PATIENT HAS THE PICC FOR ABOUT 4 MONTHS AND USE IT FOR ANTIBIOTIC AND BLOOD TAKING. IT IS DUAL LUMEN AND THE OTHER LUMEN STILL FUNCTIONING PROPERLY. THEY WILL ALSO CHECK WHEN PATIENT WILL COMPLETE THE ANTIBIOTIC TREATMENT. IF JUST A FEW WEEKS MORE THEY MAY JUST LEAVE IT AS IT IS. THEY WILL MONITOR CLOSELY AND ACT ACCORDINGLY. PATIENT STATUS/ INTERVENTION: PATIENT IS FINE AND STILL USING THE PICC, THE TEAM IS OBSERVING PATIENT CLOSELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973280 ↗
• MalfunctionNov 5, 2020Device Markings/Labelling Problem

  IT WAS REPORTED THAT PATIENT HAS A PICC INSERTED. ERROR IN THE GUIDEWIRE MEASUREMENT MARKING, IT WAS REVERSELY IMPRINTED. MARKING WAS SUPPOSED TO BE IMPRINTED STARTING FROM THE TIP OF THE GUIDEWIRE, HOWEVER, MARKING WAS IMPRINTED STARTING ON THE BACK END OF THE WIRE INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793498 ↗
• MalfunctionDec 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT CAME IN VIA TWITTER DIRECT MESSAGE FROM A NURSE IN SINGAPORE REGARDING A PICC LINE. NURSE REPORTED HOLE WAS FOUND ON BOTH LUMENS. UPDATED EVENT DESCRIPTION (CONTACTED RN) - PATIENT HAS A PICC INSERTED AND FOUND OUT THAT THE HUB WAS LEAKING DUE TO A SLIT HOLE AT THE CATHETER NEAR TO THE HUB. QUOTED BY RN: ¿PATIENT WAS SENT TO OBTAIN A PICC LINE AS HER VEINS WERE NOT OBTAINABLE VIA IV PLUGS ON (B)(6) 2019. SHE WAS ON IV ANTIBIOTICS SCHEDULED TO BE DRIPPED FOR HER. . . THE DR AT THE DEPARTMENT WAS NOT ABLE TO GET HER IV LINE TO SEDATE HER, THEY GAVE HER GAS MEDICATION DURING THE PROCEDURE. THE PROCEDURE COMPLETED AND SHE WENT HOME SLIGHTLY COUGHING AND SICK AFTER. SUSPECTED DUE TO THE GAS MASK. (CLAIMED BY PATIENT AND PATIENT'S MOTHER THAT PATIENT WAS NOT SICK PRIOR TO THE PROCEDURE) THROUGHOUT HER IV DRIPS. EVERYTHING WAS WELL AND SMOOTH. UNTIL MONDAY (B)(6) 2019, AT ABOUT 10 TO 1030AM, AFTER A DOSE WAS GIVEN TO HER BY MY FELLOW NURSE COLLEAGUE BETWEEN 630AM TO 7AM, PATIENT GAVE A PHONE CALL TO HER MOTHER TO SAY HER PURPLE LUMEN'S GAUZE OF THE PICC WAS WET AND WITH TRACES OF BLOOD. AND SHE REMOVED THE WET GAUZE AND REPLACED IT. I WAS SHORTLY CALLED IN BY PATIENT'S MOTHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521982 ↗
• MalfunctionDec 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT CAME IN VIA TWITTER DIRECT MESSAGE FROM A NURSE IN SINGAPORE REGARDING A PICC LINE. NURSE REPORTED HOLE WAS FOUND ON BOTH LUMENS. UPDATED EVENT DESCRIPTION (CONTACTED RN) - PATIENT HAS A PICC INSERTED AND FOUND OUT THAT THE HUB WAS LEAKING DUE TO A SLIT HOLE AT THE CATHETER NEAR TO THE HUB. QUOTED BY RN: ¿PATIENT WAS SENT TO OBTAIN A PICC LINE AS HER VEINS WERE NOT OBTAINABLE VIA IV PLUGS ON (B)(6)2019 . SHE WAS ON IV ANTIBOTICS SCHEDULED TO BE DRIPPED FOR HER. . . THE DR AT THE DEPARTMENT WAS NOT ABLE TO GET HER IV LINE TO SEDATE HER, THEY GAVE HER GAS MEDICATION DURING THE PROCEDURE. THE PROCEDURE COMPLETED AND SHE WENT HOME SLIGHTLY COUGHING AND SICK AFTER. SUSPECTED DUE TO THE GAS MASK. (CLAIMED BY PATIENT AND PATIENT'S MOTHER THAT PATIENT WAS NOT SICK PIROR TO THE PROCEDURE) THROUGHOUT HER IV DRIPS. EVERYTHING WAS WELL AND SMOOTH. UNTIL MONDAY (B)(6)2019 , AT ABOUT 10 TO 1030AM, AFTER A DOSE WAS GIVEN TO HER BY MY FELLOW NURSE COLLEAGUE BETWEEN 630AM TO 7AM, PATIENT GAVE A PHONE CALL TO HER MOTHER TO SAY HER PURPLE LUMEN'S GAUZE OF THE PICC WAS WET AND WITH TRACES OF BLOOD. AND SHE REMOVED THE WET GAUZE AND REPLACED IT. I WAS SHORTLY CALLED IN BY PATIENT'S MOTHER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521332 ↗
• MalfunctionJul 25, 2019Material Deformation

  IT WAS REPORTED BY DOCTOR THAT KINKED WIRE WAS OBSERVED IN PICC SET BEFORE USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8828830 ↗
• InjuryApr 26, 2019Entrapment of Device

  IT WAS REPORTED ONE OF THE MO TRAINEE WAS DOING THE PICC INSERTION . APPARENTLY THE GUIDE WIRE TIP IS CAUGHT AT THE DEEP AXILLA REGION. MOST OF THE GUIDEWIRE WERE REMOVED EXCEPT A PORTION OF THE FLEXIBLE TIP WHICH WAS STILL LODGED IN THE MUSCLE . THIS CAN BE SEEN UNDER ULTRASOUND . THE PICC PROCEDURE WAS COMPLETED BY INSERTING IT INTO PATIENT LEFT ARM. PATIENT IS STABLE , NO REACTION .

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8556972 ↗
• MalfunctionMar 14, 2019Leak/Splash

  IT WAS REPORTED THAT PATIENT HAD A PICC INSERTED AND FOUND OUT THAT THE HUB WAS LEAKING HENCE HAD TO REOPEN A NEW SET.

  Patient problems: No Information

  MAUDE report 8421078 ↗
• MalfunctionAug 17, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE AS THE NURSE AND DOCTOR WERE PREPPING THE PICC FOR INSERTION, IT WAS FOUND THE CATHETER HUB CLAMP WAS FAULTY AND LEAKING. A NEW SET WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7793312 ↗
• InjurySep 22, 2017Sticking; Unraveled Material; Physical Resistance

  IT WAS REPORTED BY THE THAT THE PHYSICIAN HAD DIFFICULTY THREADING THE POWER PICC (6F X 55CM) GUIDEWIRE INTO THE VEIN AS THERE WAS RESISTANCE. PHYSICIAN ATTEMPTED TWICE WITHOUT SUCCESS. THEN THE PHYSICIAN ASKED ANOTHER PHYSICIAN FOR ASSISTANCE TO TAKE OVER THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO INSERT THE GUIDEWIRE AND FOUND RESISTANCE AS WELL. HE THEN TRIED TO WITHDRAW THE GUIDEWIRE. NOT BEING ABLE TO TAKE OUT THE WIRE, HE GAVE IT A SLIGHT TUG AND REALIZED THAT THE GUIDEWIRE HAD GIVEN WAY, I.E. THE GUIDEWIRE HAD UNRAVELLED AND PART OF IT WAS STUCK INSIDE THE PATIENT. A PAEDIATRIC SURGEON WAS CALLED IN AND HE DID A CUT DOWN ON THE ARM AND TOOK OUT THE REMAINING GUIDEWIRE. APPARENTLY, THE "CURVED' TIP OF THE GUIDEWIRE WAS CAUGHT/STUCK IN THE SUBCUTANEOUS TISSUE. IT WAS REPORTED THAT THE PATIENT WAS WELL AFTER THE CUT DOWN AND DECISION WAS MADE NOT TO INSERT ANOTHER PICC INTO THE PATIENT.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6888195 ↗
• MalfunctionAug 10, 2017Kinked; Physical Resistance

  THE DOCTOR REPORTED THAT THE GUIDEWIRE IN THE PICC KIT KINKED VERY EASILY WHEN RESISTANCE WAS MET AND THE KINKED SHAPE REMAINED. IT WAS REPORTED THAT THERE WAS NOT A PROBLEM WITH THE KINKED WIRE, IT WAS PULLED BACK AND REPLACED WITH ANOTHER MANDRIL GUIDEWIRE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6784321 ↗
• InjuryAug 10, 2017Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT A PATIENT REQUIRED A D/L PICC FOR CHEMO THERAPY . REPORTEDLY, THE PATIENT WAS PREPPED FOR PROCEDURE AND THE DOCTOR PUNCTURED THE PATIENT SUCCESSFULLY AND INSERTED THE GUIDEWIRE THROUGH THE NEEDLE SMOOTHLY. THE WIRE WAS THEN INSERTED UNDER FLUORO GUIDANCE AND THE DOCTOR FOUND RESISTANCE AT AROUND THE AXILLA/FIRST RIB AREA. THE WIRE WAS REPORTEDLY NOT ABLE TO MOVE FORWARD AND HAVE CURVED BACKWARDS/UP . IT WAS STATED THE DOCTOR IMMEDIATELY STOPPED THE PROCEDURE AND INSERTED THE DILATOR FROM THE INTRODUCER SHEATH - TO MAINTAIN SITE ACCESS WHILE WORKING TO RETRIEVE THE GUIDEWIRE. DURING THIS RETRIEVAL PROCESS , IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE GUIDEWIRE SEEM TO HAVE CAUGHT ONTO SOME "TISSUE OR VALVE" AND WAS UNABLE TO MOVE IT. HE OBSERVED A SLIGHT "BUMP" ON FLUORO AND THIS TURNED OUT TO BE THE "KNOT" ON THE GUIDEWIRE. THEREAFTER, HE REPORTEDLY ALSO INSERTED A BER ANGIOGRAPHIC CATHETER THROUGH BUT UNFORTUNATELY WAS NOT ABLE TO REACH THE "KNOTTED" AREA TO SHEATH IT TO PULL IT THROUGH . IT WAS STATED THAT WITH SOME PUSHING AND TUGGING , THE DOCTOR COULD FEEL THE GUIDEWIRE COMING THROUGH THE INSERTION SITE BUT ALSO SAW ON FLUORO THAT THE "STUCK " PORTION O

  Patient problems: No Code Available

  MAUDE report 6784256 ↗
• MalfunctionApr 27, 2017Unraveled Material; Failure to Advance

  IT WAS REPORTED THAT DURING PICC INSERTION, THE INTERVENTIONAL RADIOLOGIST COULD NOT GET THE GUIDEWIRE INTO THE SVC AS IT KEPT TRACKING UP. WHEN ADJUSTING THE WIRE, THE GUIDEWIRE ALLEGEDLY UNRAVELLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525704 ↗
• MalfunctionOct 25, 2016Kinked

  FACILITY CONTACT REPORTED THAT UPON OPENING THE PACKAGE, THE NURSE OBSERVED THAT THE GUIDEWIRE WAS BENT AT THE FLEXIBLE END. THE POWERPICC WAS STILL INSERTED BUT USING A NEW GUIDEWIRE. ON 10/06/2016 - RETURNED WIRE HAS BLOOD RESIDUE AND CONTAINS A KINK PER ENGINEER'S EVALUATION. ON 10/25/2016 - THE FACILITY CONFIRMED THAT THE GUIDEWIRE WAS NOT INSERTED IN THE PATIENT. THEY BELIEVE THE BLOOD RESIDUE FOUND ON THE WIRE IS FROM BLOOD ON THE GLOVES OF THE NURSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6056108 ↗