PowerPICC® SV Catheter 3173355Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741027567), received between Apr 4, 2018 and Jul 10, 2025 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED VIA MEDWATCH "PATIENT'S 3F SL PERIPHERALLY INSERTED CENTRAL CATHETER LINE BECAME ENTIRELY OCCLUDED, WITH REGISTERED NURSE UNABLE TO ASPIRATE OR FLUSH. INTRAVITREAL THERAPY CONSULTED AND UNABLE TO INJECT TISSUE PLASMINOGEN ACTIVATOR INTO LINE. OF NOTE, PATIENT HAS HAD KNOWN SEDIMENT WITHIN VISIBLE TUBING OF PICC. PERIPHERAL IV ACCESS OBTAINED AND PERIPHERAL STRENGTH MILRINONE INFUSION ORDERED. PATIENT TO HAVE INTERVENTIONAL RADIOLOGY CONSULT PLACED FOR NEW TUNNELED LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468125 ↗
• MalfunctionJun 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER, WRITER ENTERED ROOM AS CALL BELL GOING, PATIENT'S MOM LET WRITER KNOW THAT PATIENT'S PICC WAS OUT AND THERE WAS A VERY SMALL AMOUNT OF LIQUID ON THE FLOOR. WRITER WENT AROUND THE BED AND SAW PICC ON THE FLOOR. OLD DRESSING REMOVED, ORANGE SECURE CATH STILL IN PATIENT'S ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302262 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC LINE CRACKED RIGHT OUTSIDE OF THE INSERTION SITE. IV TEAM TO BEDSIDE IN THE MORNING TO ACCESS PATIENT'S LEFT ARM PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DRESSING. IV TEAM NOTIFIED BEDSIDE RN THAT PATIENT'S LEFT ARM PICC DRESSING WILL NEED TO BE CHANGED DUE TO DRESSING LIFTING ON THE SIDES AND THAT PEDIATRIC INTENSIVE CARE UNIT (PICU) RNS ARE ABLE TO CHANGE THIS PATIENT'S PICC LINE DRESSING. PICC LINE FLUSHING AND BLOOD RETURN PRESENT, DESPITE NEEDING TISSUE PLASMINOGEN ACTIVATOR (TPA) AT 6AM. BEDSIDE RN AND A SECOND RN CHANGED PATIENT'S PICC LINE. PICC LINE HAD NEWER STATLOCK HOLDING IT IN PLACE. SECOND RN ATTEMPTED TO STABILIZE PICC WHILE BEDSIDE RN CLEANED AND PUT ON NEW DRESSING. AFTER DRESSING CHANGE WAS COMPLETE, BEDSIDE RN NOTICED BLEEDING AT INSERTION SITE. BEDSIDE RN FLUSHED PICC LINE EASILY AND PICC LINE STILL HAD GOOD BLOOD RETURN. RN NOTIFIED FELLOW OF BLEEDING AT INSERTION SITE. FELLOW TO BEDSIDE TO ASSESS AND ORDERED CXR TO VIEW PLACEMENT OF PICC . FELLOW ORDERED RN TO CALL IV TEAM TO BEDSIDE TO ASSESS AS WELL. IV TEAM TO BEDSIDE TO ASSESS PATIENT'S LEFT ARM PICC LINE. IV TEAM CHANGED CAP, FLUSHED LINE, AND TRIED FOR BLOO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22205974 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY MEDWATCH DURING A ROUTINE DRESSING CHANGE ON PATIENT'S (PT'S) LEFT UPPER EXTREMITY (LUE) PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, LINE NOTED TO BE BROKEN RIGHT ABOVE THE HUB AND LEAKING BLOODY/SEROSANGUINEOUS DRAINAGE. LINE CLAMPED ABOVE THE LEVEL OF THE BREAK, CARDIAC INTENSIVE CARE UNIT (CICU) APP AND ATTENDING DR. NOTIFIED. IVT AT BEDSIDE TO ASSESS. LINE WAS ORIGINALLY PLACED IS A 3FR 13CM CT COMPATIBLE BARD SINGLE LUMEN PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110844 ↗
• MalfunctionMay 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THERE WERE TWO EVENTS WHERE THE TEARAWAY INTRODUCER WAS NOTED TO BE DAMAGED UPON OPENING THE PACKAGING. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031928 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, MONDAY, (B)(6) 2025, THE PATIENT MENTIONS THAT SINCE THE PREVIOUS EVENING, HER POWERPICC CATHETER HAS BEEN LEAKING DURING USE. DRIP WATER LEAKAGE AT THE JUNCTION OF THE PURPLE PLASTIC FIN AND THE PURPLE TUBING, THE OUTER PART OF THE POWERPICC. PATIENT FASTING, INSTALLATION OF A PERIPHERAL VENOUS ACCESS FOR THE ADMINISTRATION OF ANTIBIOTIC THERAPY. BLOOD TEST DONE INSTEAD OF USING THE CENTRAL ACCESS. LONGER DELAYS FOR THE APPOINTMENT. REMOVAL OF THE POWERPICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980252 ↗
• MalfunctionJul 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THE POWERPICC BREAKS AT INTERSECTION TO FIXATOR, VISIBLE FLUID LEAK NON-REPAIRABLE CATHETER NOT ANESTHESIA. INSTALLATION OF VENOUS LINE FOR ADM ANTIBIOTIC THERAPY. REMOVAL OF PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19799750 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, "LEAKING PICC LINE. OBSERVED HOLE ON PICC LINE BETWEEN HUB AND SECUR-A-CATH, CLOSE TO INSERTION SITE. PICC INSERTION SITE UNDER OLD DRESSING, BUT DRESSING WAS PEELED UP LEAVING THE HOLE EXPOSED AND NOT UNDER DRESSING OR CLAMPED AT TIME OF ASSESSMENT. HOLE COMPLETELY EXPOSED TO ENVIRONMENT. HOLE SIZE OF BALLPOINT PEN. WRITER AND OTHER IR NURSE PERFORMED STERILE DRESSING CHANGE AND COVERED HOLE WITH DRESSING. CHARGE NURSE AND RESIDENT DOCTOR MADE AWARE." ADDITIONAL INFORMATION RECEIVED 08 FEBRUARY 2024: ANOTHER PICC WAS INSERTED. IMPACT ON THE PATIENT IS UNKNOWN. ON DAY OF ASSESSMENT THE PATIENT APPEARED WELL AND WAS BEING CARED FOR ON AN INPATIENT UNIT. UNKNOWN WHAT CAUSED THE SLIT/HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812605 ↗
• MalfunctionJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE FOUND TO BE BROKEN/LEAKING. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 01/02/2024: BROKE AT WINGS ¿ HAD BEEN IN 43 DAYS, LINE NEEDED TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED 01/04/2024: PARTIAL BREAK, CRACKED/LEAKED FROM AREA AROUND WINGS. TO MY KNOWLEDGE PATIENT DID NOT HAVE RETAINED FRAGMENTS OR IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491508 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE FOUND TO BE BROKEN/LEAKING. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 01/02/2024: RED LUMEN CRACKED - HAD BEEN IN 11 DAYS, LINE NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18487632 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC LINE SNAPPED WHERE FLEXIBLE CATHETER MEETS HUB. UNABLE TO CONTINUE USING BROKEN LINE, LINE REMOVED AT BEDSIDE. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION PROVIDED 01/02/2024: LEAKING AT WINGS - HAD BEEN IN 41 DAYS, LINE NEEDED TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED 01/04/2024: PARTIAL BREAK, CRACKED/LEAKED FROM AREA AROUND WINGS. TO MY KNOWLEDGE PATIENT DID NOT HAVE RETAINED FRAGMENTS OR IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18106845 ↗
• MalfunctionOct 26, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC FOUND "BROKEN." NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6)( 2023: DIRECT PATIENT INVOLVEMENT THAT RESULTED IN LINE REPLACEMENT, NO DELAY IN TREATMENT REPORTED. THE BREAK WAS EXTERNAL AND THERE WAS NO PIECES RETAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016171 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED BY CUSTOMER THAT FOUND A PICC BROKEN. ADDITIONAL INFORMATION RECEIVED 10/23/2023: IT WAS REPORTED BY THE CUSTOMER "THE BREAK WAS EXTERNAL; NO PIECES WERE RETAINED IN THE PATIENT. NOT AWARE OF ANY DELAYS TO TREATMENT AT THIS TIME. LINE REPLACEMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015911 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED VIA MEDWATCH "DRESSING CHANGE TO BE COMPLETED PER POLICY. DURING DRESSING CHANGE, STAT LOCK APPLIED AND PICC HUB COMPLETELY SEPARATED FROM PICC LINE DURING SECUREMENT. PICC HAD TO BE REMOVED DUE TO RISK FOR INFECTION AND WAS REPLACED UNDER SEDATION." ADDITIONAL INFORMATION PROVIDED 01/02/2024: BROKE AT HUB ¿ HAD BEEN IN 1 DAY, LINE NEEDED TO BE REPLACED. ADDITIONAL INFORMATION RECEIVED 01/04/2024: TO MY KNOWLEDGE PATIENT DID NOT HAVE RETAINED FRAGMENTS OR IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014111 ↗
• MalfunctionJul 11, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "CALLER STATES THAT HER FACILITY NEEDS TO PUT CATHFLO INTO A POWERPICC BECAUSE THE LINE IS OCCLUDED. CALLER REQUESTING THE PRIMING VOLUME FOR 3FR POWERPICC." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977750 ↗
• MalfunctionJun 9, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED "PT. ADMITTED WITH A BROKEN PICC LINE. PT CAME TO IR FOR A PICC REWIRE; PICC LINE WAS CRACKED IN HALF AT LUMEN SITE." NO PATIENT HARM WAS REPORTED, ALTHOUGH PATIENT NEEDED A NEW LINE PLACED OVER A WIRE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971191 ↗
• MalfunctionFeb 26, 2021Break

  IT WAS REPORTED THE PICC WAS "BROKEN AT DISTAL END WHERE TUBING CONNECTS TO CAP." NO OTHER INFORMATION WAS PROVIDED.

  MAUDE report 11387796 ↗
• MalfunctionJan 20, 2021Break

  IT WAS REPORTED PICC PLACED (B)(6) 2020 TO RIGHT UPPER LEG FEMORAL VEIN FOR MILRINONE INITIALLY, KEPT IN FOR LAB DRAWS AND PROPHYLACTIC ANTIBIOTICS, RELIABLE ACCESS. 'BROKE DISTAL TUBE WHERE CAP CONNECTS NOTED ON (B)(6) 2020. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2021: THE DEVICE WAS NOT KEPT. OTHER THAN ANESTHESIA, NO PATIENT HARM WAS REPORTED. IR REMOVED AND REPLACED LINE ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11203223 ↗
• MalfunctionJan 5, 2021Break

  IT WAS REPORTED "BROKEN AT END OF TUBING WHERE CAP ATTACHES. NO APPARENT PATIENT HARM. IR EXCHANGED FOR NEW BUT FAILED TO KEEP BROKEN LINE. SECURED WITH NEOSTAT, NO APPARENT PATIENT HARM"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11118227 ↗
• MalfunctionNov 25, 2020Break

  IT WAS REPORTED PICC LINE PLACED (B)(6) 2020 AND BROKE (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED 11/10/2020: IT WAS REPORTED THE LINE WAS SECURED WITH NEOSTAT, BROKEN AT THE DISTAL END OF TAIL AT HUB CONNECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10906200 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THE SV PICC LINE WAS PLACED (B)(6) 2020 AND BROKE ON (B)(6) 2020. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10615096 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED A SV PICC LINE WAS PLACED (B)(6) 2020 AND BROKE ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10615069 ↗
• MalfunctionAug 27, 2020Break; Break

  IT WAS REPORTED SV PICC LINE BROKE. ADDITIONAL INFORMATION RECEIVED 08/07/2020: IT WAS REPORTED THIS PICC BROKE WHERE THE HUB MEETS THE EXTENSION LEG. THIS WAS AN IN-PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462903 ↗
• MalfunctionJun 19, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED PT WAS "SEEN IN ER; TPAD FOR FULL OCCLUSION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176762 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THERE WAS "REPORT OF PICC LINE BROKEN AT HOME." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176725 ↗