PowerPICC Provena S1385108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741154966), received between Apr 25, 2019 and Feb 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH THAT LINE CHANGE OUT - WHITE LUMEN TUBING HAD A HOLE IN IT. NO HARM TO PATIENT. LINE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277431 ↗
• MalfunctionJun 24, 2025Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER LEAKING FROM THE T-PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319192 ↗
• MalfunctionJun 23, 2025Defective Component; Defective Component

  IT WAS REPORTED WE HAVE HAD AN INCIDENT WHERE THE T CONNECTOR THAT HOUSES THE PICC STYLET SEPARATED WHILE FLUSHING DURING CATHETER INSERTION. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310204 ↗
• MalfunctionFeb 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC WAS PLACED (B)(6) 2024 AND DISCONTINUED (B)(6) 2025 AFTER PATIENT COMPLAINED OF MODERATE PAIN DURING FLUSHING AND INFUSIONS. ALSO COMPLAINED OF LEAKING OF FLUIDS AT INSERTION SITE. WHEN REMOVED, THE LINE WAS FOUND TO HAVE 1 BREAK IN THE PICC LINE. THIS BREAK WAS VERTICAL AND WAS AT/NEAR THE 6CM MARK. TEMPORARY PAIN AND MILD SWELLING TO UPPER ARM IN REGARDS TO IVF INFILTRATION. NO PERMANENT DAMAGE DISCOVERED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21329046 ↗
• MalfunctionAug 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT HUB JUST POPPED OFF. ADDITIONAL INFO RECEIVED ON V14 AUGUST 2023: PATIENT ADMITTED TO FACILITY ON (B)(6) 2023. RA WAS PART OF THE TRANSITION OF PATIENTS MOVING FROM THE OLD ICU TO THE NEW PAVILION ICU WHEN THE NURSE NOTICED THAT THE WHITE HUB ON THE PICC LINE WAS LAYING IN THE BED. THE NURSE STATED THAT THERE WAS NO TUGGING OR PULLING ON THE LINES DURING THE MOVE AND THAT NO INFUSIONS WERE RUNNING AT THE TIME. THE PICC CATHETER AND DRESSING WAS INTACT, ONLY THE WHITE HUB WAS DETACHED FROM THE HUB LINE OF THE PICC. PRODUCT WAS INTACT AND DWELLING IN RA'S RIGHT ARM SINCE PLACEMENT ON (B)(6) 2023. IT APPEARS THAT IT IS A HUB DETACHMENT. THE EVENT DIRECTLY INVOLVED THE PATIENT. THE PICC CATHETER HAD TO BE REPLACED. THE EVENT INVOLVED AN URGENT REPLACEMENT OF THE PICC CATHETER D/T DRUG INFUSIONS NEEDING TO BE RESTARTED. NO PATIENT HARM OR COMPLICATION CAME FROM THE EVENT, AN EVENT REPORT WAS WRITTEN UP AND A NEW PICC LINE HAD TO BE PLACED. NO NEGATIVE IMPACT OCCURRED TO THE PATIENT. AFTER TRANSITION TO THE NEW PAVILION ICU, A NEW PICC LINE WAS ESTABLISHED, AND THE PATIENT RECEIVED HER INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558361 ↗
• MalfunctionJul 16, 2021Defective Component; Defective Component

  IT WAS REPORTED GUIDEWIRE GOT HUNG UP ON REMOVAL-CUSTOMER STATES THAT IT FEELS LIKE THERE'S A BURR IN THE WIRE. NO OTHER INFORMATION WAS PROVIDED. 06/24/2021: THE PROXIMAL END OF THE COIL WIRE WAS PEELED AWAY FROM THE CORE WIRE AND PROTRUDED FROM THE WIRE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12184332 ↗
• MalfunctionApr 25, 2019Break; Failure to Advance; Detachment of Device or Device Component; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT DIFFICULT TIME ADVANCING THE PICC LINES INTO APPROPRIATE POSITION AND WERE MEETING RESISTANCE IN AREAS OF THE VEIN. AFTER THE PROCEDURES WERE DONE, WE HAD FOUND THE STYLET WIRE INSIDE THE PICC CATHETERS WAS BENT AT ALMOST A 90 DEGREE ANGLE AND THE WIRE TIP BROKE OFF. IT BROKE WHEN THE WIRE WAS OUTSIDE THE PATIENT'S VEIN UPON INSPECTION OF THE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552146 ↗