PowerPICC SV Catheter 1173118Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741086892), received between Mar 30, 2017 and Mar 18, 2026 — classified as 1 injury, 15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN INFUSION PROCEDURE, A DOWNSTREAM OCCLUSION ALARM ACTIVATED. WHEN DRESSING WAS REMOVED, BLOOD WAS NOTED, AND IT WAS OBSERVED THAT THE PICC LINE HAD CRACKED AT THE BOTTOM OF THE WHITE BARD COMPONENT. THE EVENT OCCURRED ON (B)(6) 2026. IT WAS REPORTED AS NO APPARENT HARM, THOUGH THE PATIENT EXPERIENCED INCONVENIENCE, AND THE INCIDENT RESULTED IN UNEXPECTED OR PROLONGED CARE. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24633976 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED BY CUSTOMER THAT PICC LINE HAS BROKEN AT THE DISTAL END JUST BEFORE THE NEEDLELESS CONNECTOR. IT WAS REPORTED THAT THE INCIDENT OCCURRED ON FEBRUARY 9, 2026. THE PICC LINE WAS INSERTED ON 05 JAN 2026 TO THE BASILIC VEIN. ADDITIONAL INFORMATION RECEIVED 25 FEB 2026 THE PICC LINE WAS REMOVED IN THE OR AND DISCARDED. THE PATIENT WAS REQUIRED TO BE TRANSFERRED FROM A COMMUNITY HOSPITAL TO ACH FOR REMOVAL AND A NEW LINE PLACED UNDER ANESTHESIA. THIS IS AN ESCALATION OF CARE AND WOULD CLASSIFY THAT AS A SERIOUS SAFETY EVENT. PATIENT DID NOT HAVE ANY COMPLICATIONS FROM THE LINE BREAKAGE OR REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533755 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT'S PICC LINE FOUND TO BE BROKEN JUST ABOVE THE WHITE HUB. SMALL CRACK NOTED WHERE BLOOK AND SALINE LEAKED OUT WHEN FLUSHING. CRACK APPEARED TO HAVE BEEN CAUSED BY BENDING OF THE PICC AT THE AC. NO HARM TO PATIENT. PIV PLACED AND THEN NEW PICC INSERTED AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428708 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE PEDIATRIC PATIENT'S ACF PICC LINE FOUND TO BE BROKEN JUST ABOVE THE WHITE HUB. SMALL CRACK NOTED WHERE BLOOD AND SALINE LEAKED OUT WITH FLUSHING. THIS PICC LASTED LESS THAN A MONTH. CHANGE THE INSERTION LOCATION SO THAT THE LINE IS NOT BEING BENT AT THE AC SPACE DUE TO THE EXTERNAL LENGTH OF THE LINE. MINIMAL HARM TO PATIENT. PICC LINE HAD TO BE REMOVED IN THE HOT CLINIC; PATIENT WILL REQUIRE A NEW CVC LINE TO CONTINUE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388479 ↗
• MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THIS PICC HAD A CRACK OR HOLE IN IT AT THE 10 CM MARK. ON (B)(6) 2025, IT WAS FOUND WHEN SALINE WAS PUSHED AND THERE WAS LEAKAGE AT THE SITE. AFTER ADJUSTING AND PUSHING MORE THE PATIENT REPORTED SOME TENDERNESS UP THE ARM AND MORE FLUID WAS NOTED. THE PICC WAS REMOVED AND THEN FLUSHED WITH SALINE TO IDENTIFY THE HOLE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Discomfort

  MAUDE report 22061793 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED BY THE CUSTOMER, ON (B)(6) 2024 AT 1430, NURSE MOVED THE PATIENT FROM WHEELCHAIR TO BED, CHANGED THE GOWN AND CLEANED THE PATIENT WITH ANOTHER NURSE, AND HEARD A SNAP SOUND WHILE CHANGING THE GOWN. NURSE FOUND THE PICC ON THE LEFT UPPER ARM WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182497 ↗
• MalfunctionJun 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC REMOVED DUE TO LEAKING, WHEN TESTED, NOTED BULGING AT THE 1.5CM FROM HUB (0.5CM MARK) AND A LEAK. NO APPARENT HARM, REACHED PATIENT INCONVENIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610862 ↗
• MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC TUBING LEAKING, APPEARS TO BE LEAKING FROM WHERE THE TUBING ENTERS THE WINGS OF THE DEVICE. INCIDENT OR PROBLEM INFORMATION. DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2023. LEVEL OF HARM/IMPACT OF INCIDENT: PATIENT REQUIRED NEW PICC INSERTION, INCLUDING UNPLANNED OR TIME AND SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443778 ↗
• MalfunctionFeb 17, 2021Material Deformation

  IT WAS REPORTED VIA MEDWATCH "STYLET HAS CONCERNING KINK THAT LOOKS LIKE IT COULD HAVE EASILY FRACTURED INSIDE PATIENT. THERE WAS MINIMAL RESISTANCE ADVANCING OR RETRACTING CATHETER DURING PROCEDURE. NOTHING ABOUT THE PROCEDURE MAKES NURSE BELIEVE IT MAY HAVE CAUSED SUCH A SEVERE KINK IN STYLET." ADDITIONAL INFORMATION PROVIDED 2/9/2021: IT WAS REPORTED KINK FOUND AFTER PLACEMENT. MINIMAL RESISTANCE ADVANCING OR RETRACTING CATHETER DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11340833 ↗
• MalfunctionOct 14, 2020Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRODUCT WAS INSERTED (B)(6) 2020 WITH A CONFIRMED PLACEMENT. ON (B)(6) 2020, THE PATIENT RETURNED TO ED NOTING THAT THE PICC LINE HAD BEEN LEAKING. IT WAS FURTHER REPORTED THAT THE PICC LINE WAS REMOVED AND A SLIT WITH A LENGTH OF 1 CM WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10681176 ↗
• InjuryMar 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED PER RECEIVED MEDWATCH "A RIGHT SIDED PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS PLACED IN PATIENT. A FOREIGN BODY APPEARED ON CHEST X-RAY. A FEW WEEKS LATER A FOREIGN BODY WAS OBSERVED ON THE CHEST X-RAY IN THE PATIENT'S LOWER PULMONARY FILED. THE FOREIGN BODY IS MOST LIKELY A RETAINED FRAGMENT OF THE FLEXURA GUIDE WIRE (NITINOL WITH STRAIGHT TIP 0.018 IN WIDTH.) THE PATIENT WAS TAKEN TO THE CATH LAB FOR A 3 HOUR PROCEDURE. THE ATTEMPTED RETRIEVAL OF THE WIRE FRAGMENT WAS UNSUCCESSFUL."

  Patient problems: Foreign Body In Patient

  MAUDE report 9823413 ↗
• MalfunctionJun 28, 2018Crack

  IT WAS REPORTED THAT PATIENT WAS FROM OPAT PROGRAM. LINE ALLEGEDLY CRACKED AT ABOUT 7CM MARK, (2CM BELOW SKIN) , AND LINE WAS STILL ASPIRATING. AT THE MOMENT NO HARM TO PT. LINE WAS EXCHANGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648745 ↗
• MalfunctionMay 1, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT "A TUBING LEAKED AT A LOCATION IT SHOULD NOT HAVE ANY LOSS OF FLUID." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478336 ↗
• MalfunctionMay 1, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS LEAKING. THE DEVICE WAS CLAMPED AND HEPARIN LOCKED UNTIL THE VASCULAR ACCESS TEAM COULD ASSESS. THE NEXT DAY THE CATHETER WAS FLUSHED WITH NORMAL SALINE AND NOTED LEAKING FROM THE JUNCTION OF THE CATHETER AND THE WINGS. BLOOD RETURN WAS STILL NOTED, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7478291 ↗
• MalfunctionMar 29, 2018Break

  IT WAS REPORTED THAT THE THERE WAS A BREAK IN THE CATHETER PRESENT AT 8CM MARK, BREAK EXTENDED 0.5CM, TIP OF CATHETER INTACT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7383943 ↗
• MalfunctionMar 30, 2017Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED VIA MEDWATCH THAT DURING A BLOOD DRAW, BLOOD WAS DETECTED UNDER THE PICC DRESSING. A PIN HOLE WAS FOUND LOCATED BETWEEN THE CATHETER AND THE HUB, THIS WAS A SOURCE OF A BLOOD LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6445835 ↗