PowerPICC Catheter 3386105Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028212), received between Dec 19, 2017 and May 12, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED, PICC BROKE OUTSIDE OF THE BODY OF THE PATIENT. CUSTOMER SUSPECTS MATERIAL FATIGUE - BY BENDING OF THE BODY-PART. CATHETER WAS FIXED WITH STATLOCK AND SECURACATH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006771 ↗
• MalfunctionJul 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THE PATIENT HAD A NEW CATHETER EXCHANGE ON A 6FR TL POWERPICC ON (B)(6) AT NIGHT. ADDITIONAL INFORMATION RECEIVED 7/13/2023: CATHETER WAS REPLACED DUE TO A LEAK. THE DOCTOR PASSED THE CATHETER, THERE WAS NO FLOW AND REFLUX, AN IMAGE EXAM WAS PERFORMED AND DETECTED THE NEED FOR THIS EXCHANGE, DR. CAN COMPLEMENT AS NECESSARY. THE CATHETER WAS EXCHANGED IN A SURGICAL CENTER BY THE SAME DOCTOR WHO DID THE PREVIOUS ONE. PATIENT RECEIVED SEDATION, AND THE PATIENT AND FAMILY WERE DISSATISFIED, BUT NO INFECTION, FOR THE TIME BEING IDENTIFIED. DR. FOLLOWED THE CASE CLOSELY. TREATMENT CONTINUED WITH THE NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366797 ↗
• MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CATHETER LEAKS IN ONE OF THE PORTS (EXTERNAL SIDE, NOT INSIDE THE PATIENT'S SKIN). MEDICAL STAFF PREFER TO CHANGE THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 17302046 ↗
• MalfunctionSep 29, 2022Break; Fluid/Blood Leak; Defective Component; Break; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED THERE WAS AN AVULSION OF THE PICC WITH RUPTURE OF THE STABILIZATION PLATFORM (BUTTERFLY) WAS DETECTED, WHICH WAS WITH A 3.0 MONONYLON SUTURE THREAD. THERE WERE NO CLEAR SIGNS OF TRAUMA/TRACTION IN THE PATIENT'S UPPER LIMB, ANALYSIS OF THE IMAGES PERFORMED TO VERIFY THE CARE PROVIDED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504961 ↗
• InjuryAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PIC CATHETER HAD EXTRAVASATION WITHIN 48 HOURS, REQUIRING SURGICAL RE-APPROACH. A HOLE WAS OBSERVED IN THE CATHETER EXTENSION.

  Patient problems: Extravasation

  MAUDE report 15196063 ↗
• MalfunctionDec 19, 2017Unraveled Material

  IT WAS REPORTED THAT THE STYLET UNRAVELED UPON REMOVAL FROM THE PICC. THE PICC WAS REMOVED FROM THE PATIENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130673 ↗