PowerPICC Catheter 3275335Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00801741027949), received between Apr 7, 2017 and Dec 10, 2025 — classified as 1 death, 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Material Frayed; Material Frayed

  ADDITIONAL INFORMATION RECEIVED (B)(6) 2025: THE 4MM FRAGMENT WAS LEFT IN THE PATIENT¿S SOFT TISSUE AS IT WAS DEEMED SAFER THAN ATTEMPTING TO RETRIEVE. NO OTHER COMPLICATIONS OR RESIDUAL HARM OCCURRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23768635 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT A NEW PICC WAS PLACED ON (B)(6) 2025 AND VERIFIED ACCESS. HOWEVER, WHEN THE NP ATTEMPTED TO ASPIRATE THE BARE PICC NO ADAPTERS, SHE HEARD A WHISTLING SOUND AND WAS ABLE TO PULL BACK AIR ON ONE LUMEN. CATHETER WAS REMOVED AND REPLACED WITH A PICC FROM A DIFFERENT LOT. THE PROCEDURE WAS ELONGATED DUE TO TROUBLESHOOTING AND EXCHANGE, THIS WAS THE PATIENT'S THIRD PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073181 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT A PATIENT HAD A PICC LINE PLACED ON (B)(6) 2025, WHICH WAS SUBSEQUENTLY REMOVED BY THE INFUSION CENTER DUE TO LEAKAGE SPECIFICALLY FROM THE LINE ON (B)(6) 2025. LEAK WAS NOT FROM THE INSERTION SITE BUT THE LUMEN. IT WOULD DRAW BACK AIR AND MAKE A WHISTLING NOISE FROM BOTH LUMENS. THE IV TEAM WAS CALLED AND VERIFIED AN ISSUE WITH THE LINE BEFORE REMOVAL. THE PROCEDURE WAS ELONGATED DUE TO TROUBLESHOOTING AND EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073167 ↗
• MalfunctionSep 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT A NEW PICC WAS PLACED ON (B)(6) 2025 AND VERIFIED ACCESS. HOWEVER, WHEN THE NP ATTEMPTED TO ASPIRATE THE BARE PICC NO ADAPTERS, SHE HEARD A WHISTLING SOUND AND WAS ABLE TO PULL BACK AIR. BOTH LUMENS SHOWED THE SAME ISSUE. CATHETER WAS REMOVED AND REPLACED. THE PROCEDURE WAS ELONGATED DUE TO TROUBLESHOOTING AND EXCHANGE; THIS WAS THE PATIENT'S SECOND PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073025 ↗
• MalfunctionJul 14, 2025Defective Component; Defective Component

  IT WAS REPORTED, UNABLE TO LOCK THE PICC LINE DUE TO MALFUNCTION OF THE CLAMP MECHANISM, WHICH CAUSED AN INTERRUPTION DURING THE PROCEDURE THEN NEED TO OPEN NEW PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501559 ↗
• MalfunctionMar 28, 2024Defective Component; Defective Component

  IT WAS REPORTED CLAMP IS NOT FUNCTIONING (UNABLE TO CLOSE). THE DEFECTIVE PRODUCT WAS FOUND AFTER OPENING THE PACKAGE, BUT BEFORE USE WITH PATIENT SO NEW PACKAGE NEEDED TO BE OPENED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991686 ↗
• DeathJan 10, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER FEMALE PATIENT IN HER 30'S WITH A PERIPHERALLY INSERTED CENTRAL CATHETER HAD A SUDDEN CARDIAC ARREST AT HOME. RESUSCITATIVE EFFORTS AT HOME AND IN HOSPITAL WERE UNSUCCESSFUL. AUTOPSY WAS COMPLETED IN THE FORENSIC PATHOLOGY UNIT OF HOSPITAL. DEATH WAS ATTRIBUTED TO PULMONARY HYDROPHILIC POLYMER EMBOLISM. THE FORENSIC PATHOLOGIST ATTRIBUTED THIS TO THE PERIPHERALLY INSERTED CENTRAL CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Embolism/Embolus

  MAUDE report 18488802 ↗
• MalfunctionAug 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRODUCT HAS A DEFECT (BENDED GUIDEWIRE) SO CAN'T BE USED WITH PATIENT AND NEED TO OPEN NEW PACKAGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586248 ↗
• MalfunctionMay 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT, "A PIECE OF HUMAN HAIR HAS BEEN FOUND IN THE PACKAGE AFTER OPENED SO THE PRODUCT WAS CONSIDERED AS CONTAMINATION AND CAN'T BE USED, THEN THE NEW ONE HAD TO BE REPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16933863 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER "RED LUMEN ON 5F DUAL LUMEN PICC BROKE OFF. THE PICC WAS PLACED IN IR ON (B)(6) 2023 CATHETER STARTED LEAKING ON (B)(6) 2023 AND COMPLETELY BROKE OFF ON (B)(6)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820401 ↗
• MalfunctionApr 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT "POWER PICC CAME OUT LAST NIGHT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678562 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "GETTING IV MEDICATION IN PICC LINE STARTED LEAKING AT END OF INFUSION. RED LUMEN LEAKING AT HUB CONNECTION. LINE CLAMPED CLEANED WITH ALCOHOL AND GAUZE AND TAPED APPLIED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952068 ↗
• MalfunctionJul 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "GETTING IV MEDICATION IN PICC LINE STARTED LEAKING AT END OF INFUSION. RED LUMEN LEAKING AT HUB CONNECTION. LINE CLAMPED CLEANED WITH ALCOHOL AND GAUZE AND TAPED APPLIED." IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952067 ↗
• MalfunctionMay 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "GETTING IV MEDICATION IN PICC LINE STARTED LEAKING AT END OF INFUSION. RED LUMEN LEAKING AT HUB CONNECTION. LINE CLAMPED CLEANED WITH ALCOHOL AND GAUZE AND TAPED APPLIED." ADD INFORMATION RECEIVED 04/19/2022: WAS THE PRODUCT USED ON A PATIENT? YES. WAS THERE ANY PATIENT HARM REPORTED? IF YES, PLEASE DESCRIBE THE HARM, HOW IT WAS TREATED AND THE OUTCOME.- NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315925 ↗
• MalfunctionFeb 25, 2022Backflow; Backflow

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "5FR DUAL PICC THAT HAD TO BE REPLACED. AFTER FLUSHING THE PORTS ONE OF THEM INSTEAD OF BEING CLEAR FROM FLUSH WILL HAVE BLOOD OR AIR IN IT. WE MADE SURE IT WAS NOT THE CAPS WE PUT ON THE END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600285 ↗
• MalfunctionFeb 25, 2022Backflow; Backflow

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "5FR DUAL PICC THAT HAD TO BE REPLACED. AFTER FLUSHING THE PORTS ONE OF THEM INSTEAD OF BEING CLEAR FROM FLUSH WILL HAVE BLOOD OR AIR IN IT. WE MADE SURE IT WAS NOT THE CAPS WE PUT ON THE END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13600235 ↗
• MalfunctionDec 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT CATHETER INTRODUCER TIP BENT AND TORE AT THE SHEATH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061262 ↗
• MalfunctionAug 20, 2021Backflow; Fluid/Blood Leak; Backflow; Fluid/Blood Leak

  IT WAS REPORTED "PICC WAS PLACED BY IR UNDER FLUORO ON 6/20. BACKFLOW OF FLUID FROM PURPLE LUMEN TO RED LUMEN WAS NOTICED ON 6/20. PICC WAS REMOVED AND NEW PICC PLACED OVER WIRE EXCHANGE ON 6/20".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350878 ↗
• MalfunctionJun 9, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED VIA MS&S "CALLER STATES HER FACILITY PLACED AN EXPIRED PICC LINE IN A PATIENT LAST WEEK. PICC EXPIRED 1/2021 (3275335, LOT NUMBER RECP1650). CALLER ASKING IF THE PRODUCT EXPIRES WHILE IN THE PATIENT OR JUST IN THE PACKAGING. NO INCIDENT NOTED BY CALLER ABOUT PATIENT AT THIS TIME." MS&S RESPONSE: "EXPLAINED TO CALLER ONCE PICC IS PLACED IN THE BODY IT DOES NOT EXPIRE. BD¿ PACKAGING REFLECTS THE TIME DURING WHICH PRODUCT IS EXPECTED TO REMAIN STABLE, OR RETAIN ITS IDENTITY, STRENGTH, QUALITY, AND PURITY, WHEN PROPERLY STORED ACCORDING TO ITS LABELED STORAGE CONDITIONS. BEYOND THIS DATE, BD¿ DOES NOT GUARANTEE THE STERILITY, SAFETY, OR STABILITY OF THE ITEM AND THEREFORE, CANNOT RECOMMEND ITS USE. BD¿ PRODUCTS WITH LABELED EXPIRATION DATES SHOULD BE USED BY THAT DATE OR DISPOSED OF ACCORDING TO FACILITY POLICY AND PROCEDURES. BD¿ HAS NO DATA TO SUPPORT USE OF EXPIRED PRODUCT, THEREFORE, HOW TO PROCEED WILL BE A CLINICAL DECISION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971112 ↗
• MalfunctionMar 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC HAD A PINPOINT LEAK BELOW THE SUTURE WINGS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422076 ↗
• MalfunctionNov 25, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "CALLER STATES HIS WIFE RECEIVED POWERPICC 3275335 (LOT REDR0612) ON (B)(6) 2019. HE STATES THE PURPLE PORT IS NOT WORKING. HEPARIN WAS INSTILLED AND NOW THE RED ONE IS NOT WORKING."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9370507 ↗
• MalfunctionNov 4, 2019Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MS&S "PATIENT STATES THAT HE HAS HAD 5 TOTAL POWERPICCS SINCE (B)(6)2018. THEY HAVE ALL BEEN DUAL LUMEN POWERPICCS AND HAVE ALL BECOME OCCLUDED AND WOULD NOT GIVE A BLOOD RETURN. HE STATES THE MOST RECENT POWERPICC 3275335 WAS PLACED LAST FRIDAY. HE STATES THE FACILITY HE IS IN AND THAT THE NURSES DO NOT KNOW WHAT THEY ARE DOING. HE STATES THE PURPLE LUMEN HAS OCCLUDED X2 SINCE PLACEMENT AND THE NURSES ARE FLUSHING AGAINST RESISTANCE. HE STATES THE PURPLE LUMEN IS STILL OCCLUDED AND THE RED LUMEN WILL NOW FLUSH AND HAS A BLOOD RETURN, BUT THE NURSES HAD FLUSHED AGAINST RESISTANCE. MS&S REP RESPONDED TO INFORM HIS PHYSICIAN TO HAVE THE POWERPICC EVALUATED. PATIENT DID NOT KNOW IF CATHFLO/TPA HAD BEEN UTILIZED WITH THE PRESENT POWERPICC." THIS REPORT ADDRESSES THE PATIENT'S CURRENT PICC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9276009 ↗
• MalfunctionJul 10, 2019Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE GUIDEWIRE WITHIN THE HOOP WAS KINKED IN TWO PLACES, NOT ALLOWING THE WIRE TO BE THREADED THROUGH THE NEEDLE. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8776685 ↗
• MalfunctionJun 6, 2019Break; Defective Component; Failure to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE THAT COMES WITH THE POWERPICC WAS DEFECTIVE. IT WAS STATED THE TIP HAD A BREAK/FRACTURE IN THE CONNECTION AND THE GUIDEWIRE WOULD NOT ADVANCE THROUGH THE ACCESS NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8676000 ↗
• InjuryMar 22, 2019Leak/Splash

  PICC LINE LEAKING FROM THE LUMEN THAT WAS NOT IN USE FOR PATIENT'S CONTINUAL MILIRINONE INFUSION. PATIENT HAS HAD 4-5 PICC LINES PLACED WITH A SHORTER LIFE SPAN/DWELL TIME THAN WOULD BE ANTICIPATED. BECAUSE OF PATIENT'S HEART, THE TIP IS PLACED IN THE CAVOATRIAL JUNCTION, WHICH IS EQUIVALENT TO THE SVC. INSERTION - REF - LOT - EXPIRATION - UDI - TYPE. (B)(6) 2018 - 3274355 - RECV0428 - 10/31/2020 - (B)(4) - DOUBLE LUMEN. (B)(6) 2018 - 3274355 - REAP1815 - 05/28/2019 - (B)(4)- DOUBLE LUMEN. (B)(6) 2018 - 3275335 - REBX2428 - 09/30/2020 - (B)(4)- DOUBLE LUMEN. (B)(6) 2017 - 3275335 - REBN0774 - 12/31/2019 - (B)(4) - DOUBLE LUMEN. (B)(6) 2017 - 3275335 - REBW1247 - 08/31/2020 - (B)(4)- DOUBLE LUMEN. (B)(6) 2017 - 3275335 - REBS1507 - 04/30/2020 - (B)(4)- DOUBLE LUMEN. (B)(6) 2017 - 3274355 - REBR0723 - 05/31/2018 - (B)(4) - DOUBLE LUMEN - INITIAL PICC LINE. REF MFR REPORT # 3006260740-2019-00642, 3006260740-2019-00648, 3006260740-2019-00646, 3006260740-2019-00647, 3006260740-2019-00644, 3006260740-2019-00645.

  Patient problems: No Patient Involvement

  MAUDE report 8455949 ↗