PowerPICC Provena S3274108PDRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741134326), received between Sep 26, 2017 and Mar 10, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE CLINICIAN EXPERIENCED AN ISSUE IN WHICH THE ITEM BROKE WHILE IN USE. THE LINE HAD BEEN SECURED WITH SUTURES. THE LINE WAS PLACED BY AN OUTSIDE FACILITY, AND THE CLINICIAN NOTICED IT WAS ALREADY BROKEN WHEN THE PATIENT ARRIVED. THE PATIENT REQUIRED PLACEMENT OF A NEW LINE, RESULTING IN DELAYS IN MEDICATION DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557960 ↗
• MalfunctionJun 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEAK NOTED FROM PURPLE PLASTIC HUB BY BEDSIDE NURSE (B)(6) 2023 ADDITIONAL INFORMATION RECEIVED 06/19/2023 PATIENT HAS HISTORY OF AML WHO PRESENTS DUE TO FATIGUE AND HEMOPTYSIS WITH LABS SIGNIFICANT FOR SEVERE THROMBOCYTOPENIA. HE RECEIVED ALL PREVIOUS CARE IN MEXICO BESIDES RECENT ADMISSION AT OSH AND FURTHER RESEARCH WILL NEED TO BE MADE INTO PRIOR TREATMENTS. S/P BRONCHOSCOPY, BIOPSY, LP, INTRATHECAL CYTARABINE. FEVER S/P PROCEDURES ON 6/9, SPIKED FEVER 6/10 AM. CONTINUES CEFEPIME AND LINEZOLID. PLAN TO REPEAT BLOOD AND URINE CULTURES AFTER 24 HOURS SINCE LAST DRAW IF PATIENT REMAINS FEBRILE. PLAN TO REPLACE PICC TOMORROW DUE TO HOLE IN ONE OF THE LINES, FUNCTIONALLY PATIENT ONLY HAS SINGLE LUMEN PICC. THIS EVENT DIRECTLY INVOLVED A PATIENT. IT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. PATIENT REQUIRED PLACEMENT OF ANOTHER PICC LINE WHICH ALWAYS RUNS THE RISK OF INTRODUCTION INFECTION. THIS RN IS NOT AWARE OF ANY MEDICATION INTERRUPTION. NEW PICC LINE WAS PLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234672 ↗
• MalfunctionJun 28, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT LEAK NOTED TO PURPLE LUMEN BY BEDSIDE NURSE ON (B)(6) 2023 AT 1857. ADDITIONAL INFORMATION RECEIVED 06/19/2023 : PATIENT IS A PREVIOUSLY HEALTHY MALE WITH PANCYTOPENIA AND PERIPHERAL BLASTS ADMITTED TO THE PICU WITH CONTINUED BLEEDING AND PANCYTOPENIA, WORK UP CONSISTENT WITH ACUTE PROMYELOCYTIC LEUKEMIA. INITIATED ON CHEMOTHERAPY (B)(6) 2023 PER AAML1331 PROTOCOL. THIS EVENT DIRECTLY INVOLVED A PATIENT. THE EVENT DID NOT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION. PATIENT REQUIRED NEW PICC LINE PLACEMENT IMMEDIATELY TO AVOID ANY INTERRUPTION IN CHEMOTHERAPY PLAN. PATIENT REQUIRED AN ADDITIONAL SEDATION EVENT FOR ANOTHER PICC LINE INSERTION. THIS RN DOES IS NOT AWARE OF ANY MEDICATION INTERRUPTION. NEW PICC LINE PLACED AS SOON AS POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221277 ↗
• MalfunctionApr 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE RN REPORTED THAT THEY'VE "HAD A COUPLE 4 FR PICCS THAT HAVE BEEN PLACED AND THEN MALPOSITION (WAS ABLE TO REPOSITION THEM)." THE EXACT QUANTITY OF AFFECTED PICCS WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971796 ↗
• MalfunctionApr 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE RN HAD ISSUE WITH ATTEMPT TO REPOSITION LINE BY FLUSHING. RN STATED, "LINE WAS CROSSING MIDLINE AND TERMINATING IN LEFT BRACHIOCEPHALIC. WHEN A TURBULENT FLUSH WAS DONE, THE LINE LOOPED IN THE RIGHT SUBCLAVIAN/AXILLARY VEIN AND COULD NOT GET LINE TO FLUSH AT ALL. I EXCHANGED THE LINE (TO THE 5FR) TO SEND PATIENT HOME WITH LONG TERM ANTIBIOTICS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971791 ↗
• MalfunctionApr 1, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THE RN INSERTED THE DILATOR AS NORMAL BUT IT WOULD NOT GO IN ALL THE WAY, THERE WAS RESISTANCE. IT WAS STATED WHEN IT WAS REMOVED THE EDGE WAS FRAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913814 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE PICC CATHETER WAS PLACED IN THE (B)(6) FEMORAL VEIN. THE PURPLE END CAME APART FROM THE CATHETER ABOUT A WEEK LATER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602611 ↗
• MalfunctionFeb 2, 2018Kinked; Sticking

  IT WAS REPORTED BY THE NURSE THAT DURING CATHETER PLACEMENT SHE PULLED THE GUIDEWIRE TO TRIM THE CATHETER, BUT THE GUIDEWIRE WAS STUCK AND APPEARED TO BE KINKED. SHE WAS ABLE TO PLACE THE CATHETER. WHEN SHE REMOVED THE GUIDEWIRE, SHE STATED IT LOOKED KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239280 ↗
• MalfunctionNov 28, 2017Leak/Splash

  THE FACILITY REPORTED TO SALES REP THAT THE PICC BEGAN TO LEAK AT THE RED PORT AND EXTENSION LEG CONNECTION. THE PICC WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065447 ↗
• MalfunctionNov 2, 2017Crack; Fluid/Blood Leak

  THE FACILITY REPORTED TO THE SALES REP THAT THE CATHETER CRACKED AND LEAKED. NO OTHER INFORMATION WAS PROVIDED BUT HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6998018 ↗
• MalfunctionSep 26, 2017Fluid/Blood Leak

  IT WAS REPORTED BY FACILITY THAT WHEN THE PICC WAS FLUSHED, IT LEAKED AND SPRAYS AT THE JUNCTION OF THE PURPLE LUMEN AND CATHETER LINE (PURPLE LUMEN BELOW THE HUB). THE CLEANING SOLUTION USED ON THE CATHETER WAS CHLORHEXIDINE 2 OR 4 %. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6895077 ↗
• MalfunctionSep 26, 2017Fluid/Blood Leak

  IT WAS REPORTED BY THE FACILITY THAT THE PROVENA CATHETER LUMEN LEAKED. THERE WAS NO REPORT TO WHICH LUMEN LEAKED OR ANY OTHER DETAILS OF THE EVENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6895019 ↗