PowerPICC Catheter 3175335Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741027697), received between Feb 24, 2022 and Sep 6, 2024 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT HUB WAS LEAKING AT THE HUB WHEN FLUID WAS FLUSHED THROUGH THE NEEDLESS CONNECTOR CAP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156228 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A DEFECTIVE SINGLE PICC LINE WAS RECOVERED. THE PATIENT HAD TO HAVE THE PICC LINE REPLACED WITH DOUBLE LUMEN THAT DID NOT LEAK. ADDITIONAL INFORMATION RECEIVED ON 3/20/2023: A SL 5FR PICC LINE WAS INSERTED AND FOUND TO BE BACKING UP WITH BLOOD AND LEAKING AT THE HUB/NEEDLELESS CONNECTOR. THE CATHETER WAS SECURED WITH STATLOCK. THERE WAS NO BREAK. PATIENT RECEIVED ROCEPHIN INFUSIONS THROUGH THE PICC AS AN OUTPATIENT. CLINICIAN STATES THE PICC WAS NOTED TO BARELY LEAK WITH FLUSHING SALINE, BUT NOT WITH INFUSION OF ROCEPHIN FOR SOME TIME. THE IR DOCTOR WAS NOTIFIED AND CLEARED THE LINE FOR USE. THE CLINICIAN STATES THAT FROM THEIR UNDERSTANDING, SEVERAL WEEKS LATER AFTER RETURNING HOME FROM HIS DAILY ROCEPHIN INFUSION, THE PATIENT CALLED, STATING THAT THE PICC WAS LEAKING AND BACKED UP WITH BLOOD. PATIENT WAS INSTRUCTED TO RETURN TO THE CATH LAB AND THE SL PICC WAS REMOVED AND A NEW DL PICC WAS PLACED. THERE WERE NO SIGNS OR SYMPTOMS OR OTHER COMPLICATIONS. THE EVENT DID NOT INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691388 ↗
• MalfunctionApr 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT A DEFECTIVE SINGLE PICC LINE WAS RECOVERED. THE PATIENT HAD TO HAVE THE PICC LINE REPLACED WITH DOUBLE LUMEN THAT DID NOT LEAK. ADDITIONAL INFORMATION RECEIVED 3/20/2023: SINGLE LUMEN 5F PICC LINE INSERTED, FOUND TO BE LEAKING AT HUB/NEEDLELESS CONNECTOR. THE CATHETER WAS SECURED WITH STATLOCK. THERE WAS NO BREAK IN THE CATHETER; THE NURSE NOTICED IT LEAKED AT THE HUB WHEN FLUSHED. THERE WAS NO CLINICAL DELAY IN TREATMENT BUT THE PATIENT DID HAVE ANOTHER PROCEDURE TO EXCHANGE THE PICC FOR A DL PICC. NO SIGNS OR SYMPTOMS OR OTHER COMPLICATIONS OCCURRED. ANCEF WAS INFUSED THROUGH THE PICC BUT THE CLINICIAN REPORTS THE PICC WAS NOTED TO LEAK JUST WITH FLUSHING WITH SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691386 ↗
• MalfunctionMar 22, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THERE WAS LEAKING AT THE HUB CONNECTION BETWEEN PICC AND CONNECTOR. ADDITIONAL INFORMATION RECEIVED ON 3/15/2023: CUSTOMER REPORTED 2 PICCS WERE USED WITH MINIMAL PROBLEM ASIDE FROM THE LEAKING AT THE HUB THEN "LIKELY REMOVED AFTER TREATMENT WAS COMPLETE." THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595362 ↗
• MalfunctionMar 22, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THERE WAS LEAKING AT THE HUB CONNECTION BETWEEN PICC AND CONNECTOR. ADDITIONAL INFORMATION RECEIVED 3/15/2023: CUSTOMER REPORTED 2 PICCS WERE USED WITH MINIMAL PROBLEM ASIDE FROM THE LEAKING AT THE HUB THEN "LIKELY REMOVED AFTER TREATMENT WAS COMPLETE." THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595359 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "TWO PICCS INSERTED AT ONE OF OUR OTHER SITES, THAT CAME BACK TO US LEAKING. THESE WERE SINGLE LUMEN, INSERTED (B)(6), LEAKS NOTICED (B)(6) AND EXCHANGES WERE DONE." ADD INFO RCVD (B)(6) 2022: IN THE REPORTED CASES, PATIENTS HAD TO UNDERGO A PICC EXCHANGE PROCEDURE. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503264 ↗
• MalfunctionSep 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "TWO PICCS INSERTED AT ONE OF OUR OTHER SITES, THAT CAME BACK TO US LEAKING. THESE WERE SINGLE LUMEN, INSERTED SEPT 1, LEAKS NOTICED SEPT 7 AND EXCHANGES WERE DONE." ADD INFO RCVD 09/16/2022: IN THE REPORTED CASES, PATIENTS HAD TO UNDERGO A PICC EXCHANGE PROCEDURE. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503243 ↗
• MalfunctionSep 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THERE HAS BEEN A LEAKING LINE IDENTIFIED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15493170 ↗
• MalfunctionJul 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICC LINE IS LEAKING BETWEEN THE END OF THE PICC AND THE CLAVE" WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOK DATE OF OCCURRENCE: (B)(6) 2022. PLACEMENT DATE: (B)(6) 2022. EXPLANT DATE: (B)(6) 2022. WAS THERE ANY PATIENT HARM REPORTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136313 ↗
• MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LEAKING." ADDITIONAL INFORMATION RECEIVED 07/12/2022: A DETAILED DESCRIPTION OF THE EVENT: PICC LINE IS LEAKING BETWEEN THE END OF THE PICC AND THE CLAVE WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOK DATE OF OCCURRENCE: (B)(6) 2022 PLACEMENT DATE: (B)(6) 2022. EXPLANT DATE: PICC STILL IN PLACE WAS THERE ANY PATIENT HARM REPORTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069948 ↗
• MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LEAKING¿. ADDITIONAL INFORMATION RECEIVED 07/12/2022: A DETAILED DESCRIPTION OF THE EVENT: PICC LINE IS LEAKING BETWEEN THE END OF THE PICC AND THE CLAVE WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOK DATE OF OCCURRENCE: (B)(6) 2022. PLACEMENT DATE: (B)(6) 2022 EXPLANT DATE: PICC WAS LEFT IN PLACE BECAUSE IT WAS ONLY NEEDED FOR 1 MORE DAY WAS THERE ANY PATIENT HARM REPORTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069897 ↗
• MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PICC LEAKING." ADDITIONAL INFORMATION RECEIVED 07/12/2022: A DETAILED DESCRIPTION OF THE EVENT: PICC LINE IS LEAKING BETWEEN THE END OF THE PICC AND THE CLAVE. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? STAT-LOK DATE OF OCCURRENCE: (B)(6) 2022. PLACEMENT DATE: (B)(6) 2022. EXPLANT DATE: (B)(6) 2022. WAS THERE ANY PATIENT HARM REPORTED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069884 ↗
• MalfunctionJul 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, "POWER PICCS INSERTED IN IR BY DIFFERENT INSERTERS ARE LEAKING AT THE HUB WHEN FLUID IS FLUSHED THROUGH THE NEEDLESS CONNECTOR CAP, THE BAXTER ONELINK. WHEN THE CAP WAS APPLIED TO A DIFFERENT CATHETER, THERE WAS NO LEAKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029230 ↗
• MalfunctionJul 13, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER LEAKING PICC. IT WAS STATED THE PICC WAS CHECKED AND IT DIDN'T SEEM TO BE CRACKED. IT'S LIKE THERE IS A PROBLEM WITH THE THREADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004583 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "COMPLAINT FROM COMPLEX CARE OF CRACKING CATHETER HUB WHEN CONNECTED TO DEAD END CAP RESULT IN PATIENT NEEDING CATHETER REPLACEMENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189480 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED "COMPLAINTS FROM COMPLEX CARE OF CRACKING CATHETER HUB WHEN CONNECTED TO DEAD END CAP RESULT IN PATIENT NEEDING CATHETER REPLACEMENT."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189477 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CATHETER PLACED IN IR FOUND LEAKING AT CONNECTION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189211 ↗
• InjuryFeb 24, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "WHEN TRYING TO SPLIT PEEL AWAY RED PART BROKE OFF AND REST OF PEEL AWAY MIGRATED INTO THE VESSEL." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13596241 ↗