PowerPICC® HF Catheter 3385108QRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741028168), received between Dec 5, 2019 and Sep 24, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED: "8/22 @ 0756, DRESSING CHANGED DUE TO LEAKING AND LIFTING UP ALONG THE SIDE. 8/22 @ 1300, VASCULAR ACCESS TEAM CALLED TO ASSESS PICC DUE TO PERSISTENT LEAKING; LEAKING WAS NOTED FROM THE INSERTION SITE, CATHETER SLOWLY PULLED BACK WITH FLUSHING AND FRACTURE NOTED A FEW CENTIMETERS DOWN ON THE INTERNAL SEGMENT OF THE CATHETER." "PLACEMENT INFO: 5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN. 12 CM EXTERNAL LENGTH; SECURACATH IN PLACE" NO PT HARM REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583563 ↗
• MalfunctionSep 24, 2020Material Deformation; Material Deformation

  IT WAS REPORTED: "8/21 @ 1430, VASCULAR ACCESS TEAM CALLED TO ASSESS GRAY LUMEN. NOTED SUBTLE KINK IN LINE. REMOVED DRESSING, STRAIGHTENED OUT THE LINE; CATHETER FLUSHED EASILY, WITH BRISK BLOOD RETURN; NEW DRESSING PLACED." "PLACEMENT INFO: 5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN. 12 CM EXTERNAL LENGTH; SECURACATH IN PLACE". NO PT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583487 ↗
• MalfunctionSep 24, 2020Fluid/Blood Leak; Failure to Infuse; Fluid/Blood Leak; Failure to Infuse

  IT WAS REPORTED: "ALL 3 LUMENS WITH CONTINUOUS INFUSIONS POST-INSERTION" "(B)(6),@ 1900, GRAY AND RED LUMENS OCCLUDED; ALTEPLASE ADMINISTERED; PATENCY RESTORED TO RED LUMEN AFTER 2 HOUR DWELL, GRAY LUMEN REMAINED OCCLUDED." "(B)(6) @ 2300, SECOND DOSE OF ALTEPLASE ADMINISTERED TO GRAY LUMEN," "(B)(6) @ 0200, WHITE LUMEN OCCLUDED, ALTEPLASE ADMINISTERED, PATENCY RESTORED," "(B)(6) @ 0300, GRAY LUMEN OCCLUDED, ALTEPLASE ADMINISTERED; 0500, GRAY LUMEN STILL OCCLUDED, PROVIDER NOTIFIED," "(B)(6) @ 2100, WHITE LUMEN OCCLUDED, ALTEPLASE ADMINISTERED; PATENCY RESTORED." "PLACEMENT INFO: "5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN. 12 CM EXTERNAL LENGTH; SECURACATH IN PLACE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10583405 ↗
• MalfunctionSep 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FACILITY EXPERIENCED AN INCIDENT IN WHICH THE 5 FR PROVENA POWERPICC HAD ISSUES WITH KINKING. ADDITIONAL INFO. REC'D 08/31/2020: "PLACEMENT INFO: 5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BASILIC VEIN. 13 CM EXTERNAL LENGTH; SECURACATH IN PLACE" "ON (B)(6) @ 0800, ALL 3 LUMENS OCCLUDED, UNABLE TO FLUSH OR OBTAIN BLOOD RETURN. VASCULAR ACCESS TEAM NOTIFIED; DRESSING CHANGED AND CATHETER REPOSITIONED." ON (B)(6) AROUND NOON, RECURRENT OCCLUSION; VASCULAR ACCESS TEAM NOTE INDICATES, ¿PICC HAD A KINK, NO BLOOD RETURN¿. CATHETER EXCHANGED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547903 ↗
• MalfunctionApr 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "VASCULAR ACCESS TEAM CONTACTED BY BEDSIDE RN STATING PICC WAS FRACTURED, LEAKING AND PATIENT REPORTING PAIN IN LEFT UPPER ARM AND LEFT SIDE OF NECK. INSTRUCTED RN TO NOT USE PICC LINE; PHYSICIAN NOTIFIED AND PLANS MADE TO REMOVE THE PICC. UNABLE TO PERFORM PICC EXCHANGE OR PLACE NEW PICC AT THAT TIME, SINCE PATIENT WAS NOT NPO. PROCEDURE SCHEDULED FOR THE FOLLOWING DAY. DUPLEX DOPPLER ULTRASOUND PERFORMED TO EVALUATE ARM AND NECK PAIN ASSOCIATED WITH PICC. NO DEEP VENOUS THROMBOSIS IDENTIFIED WITHIN THE LEFT UPPER EXTREMITY VENOUS SYSTEM."

  Patient problems: Pain

  MAUDE report 10009818 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED 5 FR TRIPLE LUMEN POWERPICC WAS PLACED IN THE LEFT UPPER ARM, BASILIC VEIN, 4 CM EXTERNAL LENGTH; SECURACATH IN PLACE. IT WAS STATED THAT THE DRESSING WAS NOTED TO BE MOIST, AND WHEN THE LINE WAS FLUSHED, LEAKING WAS NOTED FROM THE CATHETER NEAR THE BASE OF THE SECURACATH. THE CATHETER WAS EMERGENTLY EXCHANGED AS MULTIPLE VASOPRESSORS WERE INFUSING THROUGH THE PICC. THE NEW PICC WAS SECURED USING A STATLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417276 ↗
• MalfunctionDec 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED 5 FR TRIPLE LUMEN POWERPICC WAS PLACED IN THE LEFT UPPER ARM, BASILIC VEIN, 4 CM EXTERNAL LENGTH; SECURACATH IN PLACE. IT WAS REPORTED THAT ON (B)(6) 2019, THE VASCULAR ACCESS TEAM WAS CALLED FOR LINE ADJUSTMENT. THE CATHETER TIP POSITION WAS INITIALLY IDENTIFIED AS CAVOATRIAL JUNCTION. CHEST X-RAY OBTAINED THE NEXT MORNING SHOWED THE CATHETER TIP TO BE IN THE INFERIOR RIGHT ATRIUM. THERE WAS NO INTERIM CHANGE IN EXTERNAL CATHETER LENGTH. THE VASCULAR ACCESS TEAM ARRIVED AT BEDSIDE TO PERFORM A PULL-BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9417272 ↗