PowerPICC® HF Catheter 3385355QRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028205), received between Jun 1, 2016 and Feb 12, 2025 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, "CNS AT BEDSIDE WITH RN TO DO DRESSING CHANGE. WHEN NURSE WENT TO TURN PATIENT, SHE LIFTED PATIENT'S LEFT ARM AND NOTED DISCOLORATION AND EDEMA BELOW THE PATIENT'S PICC, NO OTHER LINES PRESENT. PROVIDER WAS CALLED TO BEDSIDE. ALL INFUSIONS WERE STOPPED, CLAMPED. PLASTICS CONSULT PLACED STAT. CONSULTING SURGEON CAME TO BEDSIDE. ADVISED RN NOT TO APPLY ANY COMPRESS OR ADMINISTER ANY ANTIDOTE, DUE TO MULTIPLE INFUSIONS AND DISCOLORATION ALREADY APPEARING. SERVICE WILL FOLLOW PATIENT TO ASSESS FOR ANY WOUND EVOLVEMENT. SUSPECTING PICC PRODUCT FAILURE, DUE TO PICC PLACEMENT CONFIRMED ON MORNING CHEST X-RAY." ADDITIONAL INFORMATION PROVIDED: PATIENT IMPACT: TEMPORARY PHYSICAL HARM, AS WELL AS AN EXTRA XRAY TO DETERMINE THE PICC HAD FAILED. PATIENT PRESENTED ODDLY WITH WHAT APPEARED TO BE AN EXTRAVASATION. AFTER FURTHER DIAGNOSTIC WORKUP, A DVT WAS DISCOVERED, ALONG WITH AN ANGIO-INVASIVE FUNGAL INFECTION OF THE SOFT TISSUE. WE NOW DO NOT BELIEVE THERE WAS AN EXTRAVASATION PRESENT. MEDICATION USED TO TREAT EDEMA INCLUDES MULTIPLE MEDICATIONS INCLUDING VASOACTIVES, TPN, AND ANTIBIOTICS. CATHETER WAS NOT REPLACED. PATIENT IS NOT TO HAVE ANY IV PLACED IN THE LUE THAT NOW REQ

  Patient problems: Fungal Infection; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21365874 ↗
• MalfunctionApr 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "AFTER INSERTION OF TRIPLE LUMEN PICC, ASPIRATED AND FLUSHED LINE AND AIR WAS PULLED BACK." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686257 ↗
• MalfunctionMay 10, 2019Material Puncture/Hole

  IT WAS REPORTED THAT A HOLE WAS DISCOVERED IN THE PICC IN THE CT PORT AFTER THE PATIENT HAD A CT SCAN. ON (B)(6) 2019 - ADDITIONAL INFORMATION RECEIVED STATED, "A TRIPLE LUMEN PICC LINE WAS EXCHANGED ON THIS DATE DUE TO THE MIDDLE, CT APPROVED PORT SHOWED A SIZABLE HOLE IN THE CATHETER AFTER A CT INJECTION OF CONTRAST. THE ORIGINAL PICC LINE WAS PLACED ON (B)(6) 2019. THE PATIENT WAS NOT HARMED, HOWEVER, REQUIRED A NEW LINE TO BE PLACED.".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600055 ↗
• MalfunctionJul 1, 2016Fluid/Blood Leak; Hole In Material; Kinked

  PER SALES REPRESENTATIVE, NURSE REPORTED THAT THEIR VASCULAR ACCESS TEAM WAS CALLED TO CONSULT ON A PATIENT REGARDING DIFFICULTY WITH PICCS. THEY COULD NOT GET BLOOD RETURN AND HAD DIFFICULTY FLUSHING. TEAM CHECKED FOR MECHANICAL OBSTRUCTION, FLUSHED THE PICC, AND NOTICED SALINE LEAKING FROM THE INSERTION SITE. THE TEAM RETRACTED THE PICC A LITTLE MORE, FLUSHED TWICE AND WAS ABLE TO IDENTIFY A KINK AND PUNCTURE TO CATHETER. PICC WAS REMOVED AT THE TIME THIS WAS IDENTIFIED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5765561 ↗
• MalfunctionJun 1, 2016Fluid/Blood Leak; Difficult to Flush; Hole In Material; Obstruction of Flow; Failure to Obtain Sample

  ON 05/12/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT AFTER A PICC WAS PLACED THEY WERE UNABLE TO DRAW BLOOD AND HAD DIFFICULTY FLUSHING. IT WAS SAID THAT THEY CHECKED FOR A MECHANICAL OBSTRUCTION, FLUSHED THE PICC AND THEN NOTICED SALINE LEAKING FROM INSERTION SITE. THE PICC WAS FURTHER RETRACTED, FLUSHED TWICE AND REPORTEDLY A PUNCTURE WAS NOTED. THE PICC WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5693058 ↗
• MalfunctionJun 1, 2016Fluid/Blood Leak; Hole In Material

  ON (B)(6) 2016- PER SALES REPRESENTATIVE, FACILITY REPORTED THAT AFTER A PICC WAS PLACED THEY WERE UNABLE TO DRAW BLOOD AND HAD DIFFICULTY FLUSHING. IT WAS SAID THAT THEY CHECKED FOR A MECHANICAL OBSTRUCTION, FLUSHED THE PICC AND THEN NOTICED SALINE LEAKING FROM INSERTION SITE. THE PICC WAS FURTHER RETRACTED, FLUSHED TWICE AND REPORTEDLY A PUNCTURE WAS NOTED. THE PICC WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5693057 ↗