PowerPICC Catheter 3275135Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741027925), received between Oct 13, 2016 and Dec 3, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED POST CYCLOPHOSPHAMIDE FLUSH, WENT TO DISCONNECT PATIENT FROM IV INFUSION PUMP, AS TREATMENT WAS COMPLETED, HOWEVER, SMALL AMOUNT OF ORANGE APPEARING LIQUID (DOXORUBICIN) WAS NOTED UNDERNEATH PICC DRESSING, PRIOR TO DISCONNECTING LINES. SURROUNDING SKIN DRY TO THE TOUCH. OUTER DRESSING DRY TO THE TOUCH. OLD DRESSING REMOVED, CLEANSED SKIN, FLUSHED LINES WITH NS TO CHECK FOR LEAKS, NO APPARENT LEAKS NOTED. NEW DRESSING CHANGE & LINE CARE COMPLETED. PATIENT WENT FOR IMAGING TODAY AND IT WAS NOTED THAT THERE WAS A PIN HOLE LEAK IN THE PICC LINE, NO HARM TO PATIENT.

  Patient problems: Chemical Exposure

  MAUDE report 23704424 ↗
• MalfunctionAug 11, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT DOUBLE LUMEN PICC LINE PURPLE PORT OCCLUDED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776440 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER PICC FOUND WITH PUNCTURE IN LINE. REMOVED AS PER MD ORDER. THERE WAS NO PATIENT HARM BUT CAUSED AN INCONVENIENCE AND PROLONGED CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332166 ↗
• MalfunctionMar 19, 2025Material Frayed; Material Deformation; Material Frayed; Material Deformation

  IT WAS REPORTED PICC LINE INSERTED OVER THE WIRE. WHEN THE WIRE WAS TRYING TO BE REMOVED, IT WOULD NOT COME OUT. NEW WIRE WAS INSERTED THROUGH SECOND PORT. STUCK WIRE AND PICC REMOVED AND NEW PICC LINE INSERTED. NO APPARENT HARM REACHED PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649570 ↗
• MalfunctionFeb 19, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED WARD NURSE COMPLAINED THAT POWERPICC COULD NOT WITHDRAWAL BLOOD THE NEXT DAY AFTER PICC INSERTED. DURING PICC INSERTION, IR HAS CHECKED THE PRODUCT PATENCY. BLOOD WAS ASPIRATED AND FLUSHED WITH HEPARINIZED SALINE. HOWEVER, WARD NURSE COMPLAINED TO IR THAT THE PICC COULD NOT USE FOR BLOOD WITHDRAWAL AND COULD NOT FLUSH, AFTER 1 DAY POST INSERTION. PATIENT'S ANTIBIOTIC TREATMENT WITH PICC WAS CANCELLED AND CONTINUED TREATMENT WITH PIVC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415072 ↗
• MalfunctionJul 29, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ANESTHESIOLOGIST HAS PUT IN INTRODUCER NEEDLE AND GUIDEWIRE INTO PATIENT'S BASILIC VEIN IN THE BEGINNING OF PICC INSERTION PROCEDURE. HE WAS THREADING DILATOR AND PEEL-AWAY-SHEATH OVER THE GUIDEWIRE AND PUSH DILATOR AND SHEATH INTO PATIENT'S VEIN. HOWEVER, HE FOUND IT VERY HARD TO PUSH THIS DILATOR FURTHER AS COMPARED TO HIS PREVIOUS EXPERIENCE. HE DECIDED NOT TO PUSH ANY FURTHER AND TO REMOVE DILATOR AND PEEL-AWAY-SHEATH IMMEDIATELY. HE SAW THE TIP OF THE PEEL-AWAY-SHEATH BECAME WRINKLED. HE INSTRUCTED A STAFF NURSE TO OPEN A NEW SET OF POWERPICC TO CONTINUE THE PICC INSERTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856827 ↗
• MalfunctionJul 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE KINK DURING INSERTION CAUSING THE FAILURE TO INSERT THE POWERPICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805909 ↗
• MalfunctionMay 2, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 018 GUIDEWIRE'S SOFT TIP WAS TOO SOFT, GOT BENT & CURVED EASILY WHEN ADVANCING THROUGH SUBCLAVIAN VEIN TO BRACHIOCEPHALIC VEIN. SCRUB NURSE OPENED NEW A POWERPICC SET AND FLUSH ALL TOOLS WITH HEPARINIZEDSALINE. AFTER INTRODUCER NEEDLE WAS INSERTED, SCRUB NURSE HELPED IR IN ADVANCING GUIDEWIRE INTO VEIN. HALF WAY OF ADVANCING GUIDEWIRE THROUGH SUBCLAVIAN VEIN TO BRACHIOCEPHALIC VEIN THE SOFT TIP IS BENT AND STUCK BY COILING INPATIENT'S VEIN, AFTER A FEW ATTEMPTS OF TRYING TO ADVANCE FURTHER THE GUIDEWIRE BY FLUSHING WITH STERILE NORMAL SALINE, IR STILL EXPERIENCED DIFFICULTY TO CONTINUE ADVANCING THE GUIDEWIRE TO BRACHIOCEPHALIC VEIN. IR PULLED THE 018 STAINLESS STEEL GUIDEWIRE OUT FROM PATIENT'S VEIN AND INSTRUCTED STAFF NURSE TO OPEN A NEW 018GUIDEWIRE OF COMPETITOR'S BRAND TO CONTINUE WITH POWERPICC INSERTION PROCEDURE. NO SERIOUS INJURY TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235132 ↗
• MalfunctionMar 11, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED BY THE CUSTOMER THAT POST INSERTION, THE NEXT DAY WHEREBY PATIENT'S RIGHT ARM WAS FOUND SWOLLEN AND THERE WAS NON-FUNCTIONING OF INFLOW AND OUTFLOW DESPITE BEING TROUBLESHOOTED. THERE WAS EXPOSURE TO BLOOD AS PICC LINE WAS INSERTED. THE PATIENT IS USING PERIPHERAL BRANULA INSTEAD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema

  MAUDE report 18881241 ↗
• MalfunctionSep 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT ON INSPECTION OF PICC LINE, MULTIPLE AIR BUBBLES IN CLEAR TUBING OF EACH LUMEN. CATHETER REMAINS INSITU. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730324 ↗
• InjuryAug 25, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT GUIDEWIRE UNRAVELED AND REMAINED IN THE PATIENT¿S INTERNAL JUGULAR UNMOVED WHEN THE ANESTHESIA PROVIDER TRIED TO GENTLY REMOVE IT. THE DECISION WAS MADE AMONGST THE TEAM TO CONTINUE WITH THE SCHEDULED ANEURYSM CLIPPING AND TO HAVE VASCULAR FOLLOW TO RETRIEVE THE REMAINING GUIDEWIRE VIA NECK CUTDOWN. ADDITIONAL INFO FROM CUSTOMER: (08-AUG-2023) OR STAFF FELT RESISTANCE WHEN INSERTING PICC LINE AND PATIENT SHOWED BAD SIGNS/SYMPTOMS WHEN ATTEMPTING TO REMOVE GUIDEWIRE. THE GUIDEWIRE DID NOT BREAK INTO MULTIPLE PIECES BUT UNRAVELED DURING USE INSIDE THE PATIENT. EVERYTHING WAS REMOVED. COMPLICATIONS WITH THIS ITEM CAUSED PATIENT CARE DELAYS IN THE OPERATING ROOM AND REQUIRED ADDITIONAL INTERVENTION AS PATIENT WAS MOVED TO THE ICU. PATIENT HAD A VAGAL RESPONSE WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE AND BECAME BRADYCARDIC. ONCE PATIENT WAS STABILIZED, ANESTHESIA AND ULTRASOUND WAS CALLED TO DISCOVER THAT THE GUIDEWIRE WAS IN THE PATIENT¿S INTERNAL JUGULAR (IJ). AN X-RAY WAS TAKEN AND A CARDIAC ANESTHESIOLOGIST PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAPHIC TO CONFIRM GUIDEWIRE WAS NOT IN THE HEART. THE NEUROSURGERY, X-RAY, AND CARDIAC ANESTHESIOLOGY TEAM

  Patient problems: Foreign Body In Patient

  MAUDE report 17628571 ↗
• MalfunctionAug 16, 2023

  PER ANESTHESIA RESIDENT: THEY WERE ATTEMPTING TO INSERT A PICC LINE INTO THE PATIENT'S LEFT UPPER ARM. WHILE INSERTING THE GUIDEWIRE THEY FELT RESISTANCE AND IMMEDIATELY STOPPED ADVANCING THE GUIDEWIRE. WHEN THEY GENTLY TRIED TO PULL BACK ON THE GUIDEWIRE, IT CAUSED A VAGAL RESPONSE AND THE PATIENT BECAME BRADYCARDIC. THEY TREATED THE PATIENT AND ONCE SHE WAS STABLE, THEY ATTEMPTED AGAIN TO PULL OUT THE GUIDEWIRE, BUT STILL FELT RESISTANCE. THEY CALLED FOR ANESTHESIA HELP AND GOT AN ULTRASOUND. THEY WERE ABLE TO TRACE THAT THE GUIDEWIRE WAS IN THE IJ. THEY CALLED FOR X-RAY AND A CARDIAC ANESTHESIOLOGIST ALSO PERFORMED A TEE AND CONFIRM THE WIRE WAS NOT IN THE HEART. AN X-RAY CONFIRMED THAT THE GUIDEWIRE WAS IN THE IJ NEAR THE HEAD. WITH THE NEUROSURGERY TEAM, X-RAY, AND CARDIAC ANESTHESIA PRESENT, THEY ATTEMPTED TO PULL OUT THE GUIDEWIRE. THEY WERE ABLE TO PULL QUITE A BIT OF IT OUT, BUT REALIZED IT HAD UNRAVELED AND THAT THE REMAINING WIRE WAS STILL WIRE IN THE PATIENT'S IJ UNMOVED. THE DECISION WAS MADE AMONGST THE TEAM TO CONTINUE WITH THE SCHEDULED ANEURYSM CLIPPING AND TO HAVE VASCULAR FOLLOW TO RETRIEVE THE REMAINING GUIDEWIRE VIA NECK CUTDOWN. MOST OF THE EXPOSED GUIDEWIRE W

  Patient problems: Bradycardia; Foreign Body In Patient; Laceration(s)

  MAUDE report 17555492 ↗
• MalfunctionMay 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "WENT TO A CLIENT'S HOME FOR ROUTINE PICC MAINTENANCE. NOTED AIR BUBBLES IN BOTH LUMENS OF CLIENTS PICC LINE. DENIED ANY SHORTNESS OF BREATH, CHEST PAIN OR LIGHT HEADEDNESS. NOTIFIED HOSPITAL TRIAGE OF AIR BUBBLES. HOSPITAL STATED WILL FOLLOW UP WITH CLIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898646 ↗
• MalfunctionApr 11, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE PATIENT WAS HAVING A DOUBLE LUMEN PICC LINE INSERTED. THE RADIOLOGIST ACCESSED THE PATIENTS VEIN WITH THE INTRODUCER NEEDLE AND THE NURSE TOOK THE WIRE OUT OF ITS PROTECTIVE PLASTIC COVER AND HANDED THE SOFT END OF THE WIRE TO THE RADIOLOGIST . THE TIP OF THE WIRE WAS CURLED/BENT BEFORE WE EVEN USED IT AND AFTER MANY ATTEMPTS OF TRYING TO INSERT THE GUIDEWIRE INTO THE INTRODUCER NEEDLE UNSUCCESSFULLY, WE ABANDONED USING THIS WIRE AND OPENED UP A DIFFERENT SUBSTITUTE WIRE. WE THEN PROCEEDED WITH INSERTING THE PICC LINE INTO THE PATIENT SUCCESSFULLY. IT WAS THE GUIDEWIRE THAT WAS THE ISSUE IN THIS KIT. IMPACT OF INCIDENT: CAUSED AN INCONVENIENCE BUT NO HARM TO THE PATIENT AND WE WERE ABLE TO SUCCESSFULLY INSERT THE PICC LINE." (B)(6) 2023 - THE GUIDEWIRE OF THE RETURNED SAMPLE EXHIBITED A KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715683 ↗
• MalfunctionMar 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER THAT "DOCTOR INSERTED 5F DOUBLE LUMEN PICC. WE COULD NOT REMOVE THE WIRE. I BELIEVE IT WAS WAS FROM THE PURPLE PORT BUT I AM NOT 100% CERTAIN ANYMORE." NO PATIENT OR USER IMPACT NOTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590583 ↗
• MalfunctionJan 18, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT GUIDED WIRE BENT EVEN BEFORE THEY INSERT THE PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195198 ↗
• MalfunctionNov 1, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT GUIDEWIRE PROVIDED IN THE PICC SET IS TOO FLIMSY WHICH MAKES IT HARD FOR INSERTION. AS DR WAS TRYING TO PUSH IN, THE SOFT TIP (TUNGSTEN) BROKE OFF FROM THE STAINLESS STEEL GUIDEWIRE. PATIENT STATUS/ INTERVENTION: PATIENT IS SAFE AND NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712507 ↗
• MalfunctionMay 26, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "PICC LINE INSERTED APRIL 20, DOCUMENTED FLUSHING AND LOCKING WITH PICC ACCESS. PICC OCCLUDED IN BOTH PORTS AS OF APRIL 26." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517361 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "LEAK FOUND TO LUMEN DISTAL TO CATHETER SECUREMENT DEVICE OF 5 FRENCH DUAL LUMEN PICC. NO VISUAL OPENING COULD BE SEEN. SAME NOTED DURING FLUSHING. UNABLE TO FLUSH AND LOCK DEVICE. PICC LINE NO LONGER FUNCTIONAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188447 ↗
• MalfunctionJul 18, 2019Leak/Splash

  IT WAS REPORTED PICC WAS FOUND LEAKING WHEN DOING FLUSH TEST, A LEAK WAS FROM THE BASE OF CATHETER NEAR THE SUTURE WING. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802289 ↗
• MalfunctionAug 9, 2018Leak/Splash

  IT WAS REPORTED THAT THE PICC WAS PLACED WITHOUT DIFFICULTY, A DRESSING WAS APPLIED AND THE CATHETER WAS FLUSHED. HOWEVER, WHILE THE PATIENT WAS STILL ON THE TABLE, THE DRESSING WAS NOTICED TO BE FILLING WITH DILUTED BLOODY DRAINAGE. DRESSING WAS REMOVED AND THE PICC WAS FOUND TO BE LEAKING AT THE "Y" HUB. THE PICC WAS IMMEDIATELY EXCHANGED WITHOUT DIFFICULTY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770698 ↗
• MalfunctionOct 13, 2016Kinked

  BAS ENGINEERS FOUND THAT A GUIDEWIRE RETURNED FOR EVALUATION WAS KINKED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6028881 ↗