PowerPICC® SV Catheter 3274118Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741027840), received between Apr 19, 2018 and Feb 20, 2026 — classified as 4 injuries, 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT CATHETER BROKE COMPLETELY THROUGH. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406826 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH 3M. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337542 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH 3M. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337393 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH A SUTURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335557 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER WAS FOUND WITH A HOLE JUST DISTAL TO THE HUB, DISCOVERED DUE TO LEAKAGE UNDER THE DRESSING. IV MEDICATION TREATMENT WAS INTERRUPTED, AND PATIENT HAD TO UNDERGO AN EXCHANGE OF THE LINE. LINE WAS SECURED WITH FLEXGRIP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335552 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED INFUSIONS RUNNING IN BOTH LUMENS. LUMEN 2 BLOCKED. NOT FLUSHABLE. CAP CHANGES PREFORMED. AFTER CAP CHANGE COMPLETE, LUMEN FLUSHED, LIQUID SQUIRTED OUT OF BROKEN LINE BELOW THE HUB WHERE CAP IS ATTACHED. PATIENT IMPACT UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24190268 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A LEAKING POWER PICC LINE REMOVED FOR LEAKING. ADDITIONAL INFORMATION RECEIVED: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? 1 SECURACATH. PLACEMENT DATE: LINE PLACED MAY 13 AND REMOVED MAY 23 DUE TO LEAKING NOTED AS DESCRIBED. A DETAILED DESCRIPTION OF THE EVENTS: LINE FOUND LEAKING BETWEEN 0-2 CM MARK. WAS THERE ANY PATIENT HARM REPORTED? LEAKING LINE REQUIRED REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049375 ↗
• MalfunctionJun 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WE RECENTLY HAVE HAD LEAKING POWER PICC LINE REMOVED FOR LEAKING, POSSIBLE DEFECT." ADDITIONAL INFORMATION RECEIVED 05/31/2021: PLACEMENT DATE: MAY & REMOVED WITHIN 5 -10 DAYS OF INSERTION; 5-13 PLACED/ 5-18 REMOVED DUE TO LEAKING. A DETAILED DESCRIPTION OF THE EVENTS: LINE FOUND LEAKING UNDER THE DRESSING @ HUB ON 1 & BETWEEN 0-2 CM MARK ON THE OTHER. WAS THERE ANY PATIENT HARM REPORTED? LEAKING LINE REQUIRED REMOVAL. WHAT THEY'RE BEING TREATED FOR: ONCOLOGY SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008861 ↗
• InjuryFeb 1, 2019Fluid/Blood Leak; Gas/Air Leak; Improper Flow or Infusion

  IT WAS REPORTED VIA MEDWATCH "DURING LAB DRAW AT 0440, A LOT OF GAS CAME OUT OF THE PURPLE LUMEN WITH SLUGGISH OF BLOOD RETURN. THE LINE WAS CLAMPED. MD WAS OK TO CONTINUE TO USE THE WHITE LUMEN FOR INFUSION. AT 0645, WHITE LUMEN WAS FOUND LEAKING BLOOD BY RN. THE LINE WAS CLAMPED, CHARGE NURSE AND DAYTIME MD NOTIFIED. TWO PIVS WERE STARTED FOR PT. PICC LINE WAS REMOVED BY MD AND HOSPITALIST TEAM AT 0715." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296949 ↗
• MalfunctionSep 5, 2018Fluid/Blood Leak; Material Puncture/Hole; Power Problem

  IT WAS REPORTED THAT THE FACILITY HAD A 4 FR POWER PICC PLACED (B)(6) 2018 AND REMOVED DUE TO LEAKING ON (B)(6) 20/18. 8/23/2018- ADDITIONAL INFORMATION FROM TM STATED THE PICC WAS REPLACED AS IT WAS LEAKING FROM A "VERY SMALL" HOLE NEAR THE BIFURCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7847940 ↗
• InjuryMay 4, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT'S MOTHER REPORTS HER DAUGHTER DEVELOPED A DVT AFTER HER FIRST PICC WAS INSERTED. THE PICC WAS REMOVED AND A NEW PICC WAS PLACED IN THE OTHER ARM. THE REPORTED DVT WAS IN THE SUBCLAVIAN VEIN AND WAS TREATED WITH LOVENOX INJECTION. THE PATIENT'S MOTHER REPORTS SHE (THE PATIENT) HAS CONTINUED TO DEVELOP SUPERFICIAL CLOTS AT THE SITE IS ON ONGOING LOVENOX UNTIL A DIFFERENT CATHETER CAN BE PLACED.

  Patient problems: Thrombus

  MAUDE report 7487682 ↗
• InjuryApr 20, 2018Flaked; Material Deformation

  IT WAS REPORTED THAT THE PICC WAS PLACED IN (B)(6) 2018. THE PICC REQUIRED REPLACEMENT DUE TO CONTACT DERMATITIS AND EXCORIATION. CONTACT DERMATITIS WAS SAID TO HAVE DEVELOPED SLOWLY AND INTENSIFIED OVER TIME. THE SITE UNDER THE PICC BIFURCATION IS REPORTED TO BE SEVERELY BLISTERED, BUBBLING AND FLAKING. THE MOTHER OF THE PATIENT REPORTS THEY HAVE TRIALED VARIOUS DRESSINGS, OMITTED TOPICAL CLEANING AGENTS, INCLUDE CHLORHEXIDINE, AS DIRECTED BY A DERMATOLOGIST. CURRENTLY, THEY ARE ONLY ABLE TO USE SALINE AND ALCOHOL TO CLEAN THE SITE AND STERILE GAUZE, TELFA AND COBAN CHANGED EVERY 48 HOURS TO DRESS IT AND THE PATIENT CONTINUES TO EXPERIENCE THE REACTION. PATIENT ALSO RECEIVED ORAL ANTIBIOTICS IN AN EFFORT TO TREAT THE CONTACT DERMATITIS BUT THE MOTHER STATES THE REACTION PERSISTS. THE PATIENT HAD A NORTH AMERICAN PATCH ALLERGY TESTING OF 80 SAMPLES, IT IDENTIFIED 4 CHEMICALS COMMONLY FOUND IN SURGICAL ADHESIVES, MEDICAL DRESSINGS, MEDICAL PLASTICS, SUTURES, AND WOUND CARE OINTMENTS.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7448277 ↗
• InjuryApr 19, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PICC WAS PLACED IN (B)(6) 2017. THE PICC HAD TO BE REMOVED DUE TO THE PATIENT CONTRACTING SEPSIS AS WELL AS CONTACT DERMATITIS. IT WAS STATED THAT THE CONTACT DERMATITIS IS OCCURRING ONLY AT THE PICC EXIT SITE AND UNDER THE BIFURCATION. IT IS REPORTED THAT THE REACTION DEVELOPS SLOWLY AND INTENSIFIES OVER TIME. THE SITE UNDER THE PICC BIFURCATION IS REPORTED TO BE SEVERELY BLISTERED, BUBBLING AND FLAKING. THEY HAVE TRIALED DIFFERENT DRESSINGS AND HAVE ALSO OMITTED USING DIFFERENT TOPICAL CLEANING AGENTS SUCH AS CHLORAHEXIDINE PER THE DIRECTION OF DERMATOLOGY. THEY ARE CURRENTLY ONLY USING A STERILE TELFA DRESSING CHANGED EVERY 48 HRS AND THE SKIN REACTION AND INFECTIONS PERSIST. PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND PICC REPLACEMENT IN A NEW LOCATION. THE PATIENT RECENTLY HAD NORTH AMERICAN PATH TESTING-80 SAMPLE. IT IDENTIFIED 4 CHEMICALS THAT ARE COMMONLY FOUND IN SURGICAL ADHESIVES, MEDICAL DRESSINGS, ADHESIVES, MEDICAL PLASTICS, SUTURES, WOUND CARE OINTMENTS. THE PICC IS USED FOR CONTINUOUS HYDRATION.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7445417 ↗