PowerPICC® Catheter 3275108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741027871), received between Apr 15, 2022 and Apr 11, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THE PICC WAS USED FOR AQUADEX PEDIATRIC PATIENT AND PLACED IN THE IJ. THIS LINE DWELLED IN THE PATIENT FROM (B)(6) 2023-(B)(6) 2024. THE LINE WAS DISCONTINUED AFTER THE PATIENT'S STATUS IMPROVED AND NO LONGER NEEDED AQUADEX. THE SUTURE WINGS CRACKED OFF. THEY WERE ABLE TO RE-SUTURE THE PICC AND USE IT FOR ANOTHER 2 MONTHS. THE TREATMENT WAS COMPLETED AND THE LINE WAS DISCONTINUED ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091921 ↗
• MalfunctionApr 11, 2024Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER PICC USED FOR AQUADEX PEDIATRIC PATIENT AND PLACED IN THE IJ ON (B)(6) 2021 AND THE WING CRACKED ON 3/14/24. THE LINE WAS DISCONTINUED BY PROVIDERS ON 3/19 AFTER THE PATIENT'S STATUS IMPROVED AND NO LONGER NEEDED AQUADEX. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091073 ↗
• InjuryMar 7, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC LINE) WAS INSERTED, AND THE GUIDE WIRE WAS LOST IN THE VEIN. WHEN IDENTIFIED, THE GUIDE WIRE HAD APPEARED BROKEN IN TWO AND REMOVED IN TWO PIECES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18856499 ↗
• MalfunctionNov 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC PULLS AIR WHEN CONNECTED TO EXTENSION SET. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088824 ↗
• MalfunctionApr 15, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "REPORTED AN ISSUE WITH THE TRANSITION ON THE SHEATH BEING NOT AS SMOOTH AS IT HAS BEEN IN THE PAST." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118389 ↗