PowerPICC® SV Catheter 3274108Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741027826), received between Mar 13, 2018 and Feb 18, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS LEAKING ON THE PATIENT SIDE. ADDITIONAL INFORMATION RECEIVED ON 2/4/2026: PICC PLACED WITHOUT INCIDENT, CONFIRMED TIP TERMINATION, PATENCY CONFIRMED, DRESSING APPLIED. FINAL FLUSH AFTER DRESSING APPLIED DEMONSTRATED IMMEDIATE LEAKING FROM PATIENT-SIDED HUB EDGE. NO LEAKING SURROUNDING SECUREACATH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383105 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026680 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016480 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011292 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC CRACKED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006496 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC CRACKED. PLACED (B)(6) 2024 M/O REQUIRED PATENT TO RETURN TO INTERVENTIONAL RADIOLOGY FOR REPLACEMENT OF LINE, PATIENT HAD IV'S PLACED FOR TWO DAYS AWAITING OPPORTUNITY TO RETURN TO IR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992977 ↗
• MalfunctionMay 20, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED VASCULAR ACCESS TEAM CALLED TO PATIENT'S BEDSIDE DUE TO LEAKING 4FR DOUBLE LUMEN PICC LINE. NURSE WAS TOLD BY MOTHER OF PATIENT THAT THE "WHITE PORT" OF THE DOUBLE LUMENT PICC WAS LEAKING SINCE LAST NIGHT (04/15) AT APPROXIMATELY 8:00PM AFTER THE PATIENT CAME BACK FROM HIS MRI. MOTHER OF PATIENT STATED THAT THE NIGHT NURSES WERE CHANGING THE PATIENT'S DRESSING AND FLUSHED THE WHITE PORT AND IT HAD STARTED LEAKING. NURSE FLUSHED THE WHITE PORT OF THE PICC LINE AND RIGHT AWAY THERE WAS LEAKING FROM THE HUB OF THE CATHETER, WHERE THE PICC LINE MEETINGS WITH THE HARD WHITE PLASTIC OF THE HUB. BEDSIDE NURSE WAS NOTIFIED THAT THE LINE NEEDED TO BE CHANGED AND ORDERS WERE PLACED. PICC LINE WAS REPLACED WITH A SINGLE LUMEN 3FR PICC LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354782 ↗
• MalfunctionApr 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "UPON OPENING THE 4 FR DUAL LUMEN POWERPICC KIT, THE ACCESS NEEDLE WAS OUT OF THE PROTECTIVE CAP AND LOOSE IN THE TRAY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189294 ↗
• MalfunctionApr 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "UPON OPENING THE 4 FR DUAL LUMEN POWERPICC KIT, THE ACCESS NEEDLE WAS OUT OF THE PROTECTIVE CAP AND LOOSE IN THE TRAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188074 ↗
• MalfunctionJul 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED "DRESSING WILL NOT PROPERLY ADHERE TO SKIN. COMPLAINT IS FOR ALL PICC KITS WHERE DRESSING HAS MOVED TO A PRIVATE LABEL." NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107160 ↗
• MalfunctionJan 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  4 FR DOUBLE LUMEN POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN, 10 CM EXTERNAL LENGTH; SECURACATH IN PLACE. IT WAS REPORTED THAT INSERTION PROCEDURE STOP TIME WAS 1805 ON 12/21/19. PICC WAS FLUSHED WITH HEPARIN 10 UNITS/ML 1 ML TO BOTH LUMENS. AT 1825, THE BEDSIDE RN ATTEMPTED TO OBTAIN BLOOD FROM THE RED PORT BUT WAS UNABLE TO ASPIRATE BLOOD. SHE ATTEMPTED TO FLUSH WITH A HEPARINIZED SALINE SYRINGE AND IMMEDIATELY NOTED FLUID LEAKING FROM UNDER THE SECURACATH. CONFIRMED WITH THE RN WHO INSERTED THE PICC THAT THE CATHETER WAS PROPERLY ALIGNED WITHIN THE CHANNEL OF THE SECURACATH. THE EXTERNAL CATHETER LENGTH WAS 10 CM, SO THE REVERSE TAPER WOULD HAVE BEEN OUTSIDE OF THE SECURACATH. THE PICC FLUSHED EASILY WITHOUT RESISTANCE WHEN IT WAS HEPARINIZED POST-INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9649463 ↗
• MalfunctionMar 8, 2019Break; Fracture

  IT WAS REPORTED: CATHETER WAS PLACED IN LEFT UPPER ARM, CEPHALIC VEIN; 3 CM EXTERNAL LENGTH, SECURACATH IN PLACE. CATHETER WAS REMOVED DUE TO CATHETER FRACTURE/BREAK. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405960 ↗
• MalfunctionMar 8, 2019Leak/Splash

  IT WAS REPORTED THE CATHETER WAS PLACED IN LEFT UPPER ARM, CEPHALIC VEIN; 3 CM EXTERNAL LENGTH, SECURACATH IN PLACE. RN ADMINISTERED MEDICATION THROUGH THE WHITE PORT WITH NO ISSUES; WHITE LUMEN WAS SUBSEQUENTLY FLUSHED WITH NORMAL SALINE AND HEPARIN, NO LEAKAGE NOTED. WHEN THE CAP ON THE RED PORT WAS CHANGED AND THE RED PORT WAS FLUSHED WITH NORMAL SALINE, LEAKING WAS IMMEDIATELY NOTED UNDERNEATH THE DRESSING AT/AROUND THE SECURACATH SATURATING THE DRESSING. OF NOTE, MULTIPLE DOSES OF ALTEPLASE HAD BEEN GIVEN FOR PARTIAL CATHETER OCCLUSION ON THE FOLLOWING DATES: 1/15, 1/20, 1/24, 1/27 AND 1/28, WITH PATENCY RESTORED EACH TIME. LAST CHEST X-RAY DONE ON 1/23 SHOWED CATHETER TIP IN GOOD POSITION AT CAVOATRIAL JUNCTION. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405957 ↗
• MalfunctionFeb 28, 2019Leak/Splash

  IT WAS REPORTED BY ICU RN, "LEAKING FROM THE WHITE LUMEN ON (B)(6) 2019, LINE CLAMPED AND SECURED, PT UNABLE TO BE SEDATED FOR REPLACEMENT, RED LUMEN IN USE AT THE TIME. ICU RN REPORTED RED LUMEN LEAKING AND REMOVED THE PICC. PT ALREADY SCHEDULED FOR LINE REPLACEMENT THAT DAY, SECOND LINE PLACED BEFORE THE INITIAL LINE WAS REMOVED. PICC TEAM AND ICU STAFF STATE THERE WERE NO MECHANICAL ISSUES DURING PLACEMENT, USE, OR REMOVAL OTHER THAN THE HUBS LEAKING AS DESCRIBED. PICC WAS EXPOSED TO CATHFLO ON FOUR OCCASIONS PRIOR TO LEAKING INCIDENT ¿ LUMEN(S) NOTE NOTED. PT EXPERIENCED A DELAY IN TREATMENT, IS CURRENTLY AN INPATIENT IN THE ICU, COMPLETE DX UNKNOWN AT THIS TIME. ICU NURSE EXPRESSED ANXIETY OVER IMPACT TO PT CARE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8379923 ↗
• MalfunctionNov 1, 2018Leak/Splash

  IT WAS REPORTED THE PICC WAS PLACED IN THE LEFT UPPER ARM, LEFT BASILICA VEIN WITH 3CM EXTERNAL LENGTH. THE CATHETER WAS SECURED WITH SECURACATH. IT WAS STATED THAT THE VASCULAR ACCESS TEAM NOTIFIED THAT THE PICC WAS LEAKING, DRESSING SATURATED. THE DRESSING WAS REMOVED, LINE WAS FLUSHED, AND LEAKAGE WAS NOTED FROM INSERTION SITE. THE CATHETER WAS REMOVED AND UPON FLUSHING, NOTED TO BE LEAKING NEAR THE 7CM MARK. A PERIPHERAL IV WAS PLACED, AND A NEW PICC INSERTED THE FOLLOWING DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8029170 ↗
• MalfunctionNov 1, 2018Leak/Splash

  IT WAS REPORTED THE PICC WAS PLACED IN THE LEFT UPPER ARM, LEFT BASILICA VEIN WITH 6CM EXTERNAL LENGTH. THE CATHETER WAS SECURED WITH SECURACATH. IT WAS STATED THAT THE PATIENT WAS TAKEN TO MEDICAL IMAGING FOR CT SCAN. PICC RED LUMEN WAS FLUSHED AND BLOOD RETURN OBTAINED. TUBING FROM THE POWER INJECTOR WAS CONNECTED TO THE PICC. SHORTLY AFTER CONTRAST ADMINISTRATION WAS STARTED THE PATIENT REPORTED LEAKING ON HIS ARM. ON INSPECTION, LEAKING AT THE SITE WAS NOTED. THE PATIENT WAS RETURNED TO HIS ROOM. PICC WAS REMOVED AND A PERIPHERAL IV WAS PLACED; PATIENT WAS THEN TAKEN BACK TO MEDICAL IMAGING AND CONTRAST WAS GIVEN THROUGH THE PERIPHERAL IV TO COMPLETE THE CT SCAN. PERIPHERAL IV PLACED; DELAY IN COMPLETING CT SCAN. PATIENT WAS RECEIVING PARENTERAL NUTRITION WHICH HAD TO BE STOPPED UNTIL A NEW PICC COULD BE PLACED ON MONDAY, (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028987 ↗
• MalfunctionOct 18, 2018Break; Leak/Splash

  THE FACILITY REPORTED CATHETER BREAKAGE. ADDITIONAL INFORMATION REC'D FROM FACILITY STATED: "RIGHT UPPER ARM, RIGHT BRACHIAL VEIN; 5 CM EXTERNAL LENGTH, SECURACATH IN PLACE. LEAKAGE NOTED TO BE COMING FROM BETWEEN THE BASE/COVER OF THE SECURACATH DEVICE. CATHETER WAS WELL-POSITIONED WITHIN THE SECURACATH, NO EVIDENCE OF CRIMPING. CATHETER EXCHANGE PROCEDURE REQUIRED TO REPLACE THE LINE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981101 ↗
• MalfunctionJun 28, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT AN INPATIENT PICC LUER WAS LOOSENING FROM THE TUBING WHICH "JUSTIFYING CHANGE FOR INFECTION PREVENTION." THE EXTENSION TUBING WAS NOT KINKED. THE CATHETER WAS LONG COILED 18CM OF EXTERNAL LENGTH AND DRESSED TOWARD OUTSIDE OF ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648812 ↗
• MalfunctionMar 13, 2018Hole In Material

  THE FACILITY REPORTED TO THE SALES REP THAT THE PICC WAS REMOVED DUE TO A HOLE IN THE LUMEN THAT WAS 2.25CM FROM THE RED HUB. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335819 ↗