PowerPICC SOLO2 Catheter 3194108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741027727), received between Jul 14, 2016 and Mar 3, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

2 FDA recall records name this device's identifier, 2 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 ↗

2. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025No Display/Image; No Display/Image

  IT WAS REPORTED BY THE CUSTOMER, THEY HAVE HAD TROUBLE SEEING THE WIRE UNDER FLUOROSCOPY WHEN PLACING THE PICC LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503986 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT BD PICC LINE WITH FRACTURE NOTED. FRACTURE NOTED BETWEEN THE 2-3 CM MARK WHICH WOULD HAVE BEEN 1-2CM SUBCUTANEOUS. FRACTURE CATHETER WAS REMOVED. NO PATIENT HARM OR INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377362 ↗
• MalfunctionJan 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, HOLE IN PICC. NO PATIENT IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161362 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER OF A PICC LINE WITH HOLE. NO IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045025 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AFTER ASSESSING THIS PICC LINE, I FOUND THAT IT WOULD FLUSH BUT I COULD NOT GET A BLOOD RETURN. I TOOK THE DRESSING OFF AND CUT THE SUTURE THAT WAS HOLDING THE PICC IN PLACE AND BEGAN PULLING THE PICC. I NOTICED THE PICC SEEMED A LITTLE HARDER TO PULL THAN NORMAL. I PULLED THE PICC OUT TO THE 20 CM MARK AND NOTICED IT WAS LEAKING. I CONTINUED JUST PULL THE LINE THE REST OF THE WAY DUE TO THE CRACK AT THE 20 CM MARK. THIS PICC WAS PLACED IN THIS PATIENT ON (B)(6) 2024 AND PULLED IT ON (B)(6) 2024. THE PATIENT EXPERIENCED EXTRAVASATION. THE LINE WAS USED EVERY DAY UP UNTIL THE DAY I PULLED IT. OUR INFUSION DEPARTMENT CONTACTED ME BECAUSE THEY WERE HAVING TROUBLE GETTING A BLOOD RETURN FROM THE PICC LINE, BUT THEY WERE ABLE TO FLUSH THE LINE JUST FINE. A NEW LINE WAS NOT PLACED AS THE ORDERING PROVIDER DECIDED TO TREAT THE PATIENT A DIFFERENT WAY. NO ADVERSE EVENTS HAPPENED THAT I AM AWARE OF.

  Patient problems: Extravasation

  MAUDE report 20881044 ↗
• MalfunctionDec 23, 2020Material Frayed; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "I WAS GIVEN 2EA PICC KITS, # 3194108D, THAT WERE DEEMED TO BE DEFECTIVE. THERE WAS AN ISSUE WITH THE GUIDEWIRE. IT SEEMS TO FRAY AND WAS SEVERELY COMPROMISED WHEN THEY TRIED TO USE IT. THERE ALSO IS KINKS IN THE WIRE. THE STAFF SAVED THE PACKAGING AND THE PICC'S THEMSELVES. THEY WERE FINALLY ABLE TO COMPLETE THE PROCEDURE BY USING A 5FR DUAL LUMEN." ADD INFO RCVD 11/02/2020: "THE OCCURRENCE HAPPENED ON (B)(6) AT ABOUT NOON. THE PATIENT WAS IN HIS 60S, ADMITTED FOR A SMALL BOWEL OBSTRUCTION. I DO NOT RECALL HIS HEIGHT AND WEIGHT, BUT HE WAS THIN, SO PERHAPS 65KG WITH A HEIGHT AROUND 5'7" OR 5'8". HE HAD NO KNOWN COMMUNICABLE DISEASES. I WAS ABLE TO SECURE THE BASILIC VEIN OF HIS RIGHT ARM VERY EASILY WITH THE 21G NEEDLE PROVIDED IN THE KIT. THERE WAS NO DIFFICULTY PLACING THE GUIDE WIRE, OR PLACING THE 4.5FR INTRODUCER. THREADING THE PICC WAS NOT AN ISSUE, BUT UPON REMOVAL OF THE GUIDE WIRE IN THE PICC, IT BEGAN TO UNRAVEL. I CONTINUED TO REMOVE THE GUIDE WIRE AS IT UNRAVELED, EVENTUALLY REMOVING THE PLASTIC ATTACHMENT/EXTENSION PIECE THAT COMES ATTACHED TO THE PICC IN THE HOPES THAT THE PROBLEM WAS LOCATED IN THAT PIECE. THE GUIDE WIRE CONTINUED TO UNRAVEL DESPITE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11065862 ↗
• MalfunctionDec 23, 2020Difficult to Remove; Unraveled Material; Material Deformation; Physical Resistance/Sticking; Material Deformation

  IT WAS REPORTED "I WAS GIVEN 2EA PICC KITS, # 3194108D, THAT WERE DEEMED TO BE DEFECTIVE. THERE WAS AN ISSUE WITH THE GUIDEWIRE. IT SEEMS TO FRAY AND WAS SEVERELY COMPROMISED WHEN THEY TRIED TO USE IT. THERE ALSO IS KINKS IN THE WIRE. THE STAFF SAVED THE PACKAGING AND THE PICC'S THEMSELVES. THEY WERE FINALLY ABLE TO COMPLETE THE PROCEDURE BY USING A 5FR DUAL LUMEN." ADD INFO RCVD 11/02/2020: "THE OCCURRENCE HAPPENED ON NOVEMBER 25TH AT ABOUT NOON. THE PATIENT WAS IN HIS 60S, ADMITTED FOR A SMALL BOWEL OBSTRUCTION. I DO NOT RECALL HIS HEIGHT AND WEIGHT, BUT HE WAS THIN, SO PERHAPS 65KG WITH A HEIGHT AROUND 5'7" OR 5'8". HE HAD NO KNOWN COMMUNICABLE DISEASES. I WAS ABLE TO SECURE THE BASILIC VEIN OF HIS RIGHT ARM VERY EASILY WITH THE 21G NEEDLE PROVIDED IN THE KIT. THERE WAS NO DIFFICULTY PLACING THE GUIDE WIRE, OR PLACING THE 4.5FR INTRODUCER. THREADING THE PICC WAS NOT AN ISSUE, BUT UPON REMOVAL OF THE GUIDE WIRE IN THE PICC, IT BEGAN TO UNRAVEL. I CONTINUED TO REMOVE THE GUIDE WIRE AS IT UNRAVELED, EVENTUALLY REMOVING THE PLASTIC ATTACHMENT/EXTENSION PIECE THAT COMES ATTACHED TO THE PICC IN THE HOPES THAT THE PROBLEM WAS LOCATED IN THAT PIECE. THE GUIDE WIRE CONTINUED TO UNRAVEL D

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11065717 ↗
• MalfunctionFeb 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THE 4F SL POWER PICC STYLET GOT STUCK, "WHEN THE PHYSICIAN PULLED IT STRETCHED. IT CAME OUT INTACT. IT DID NOT BREAK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700449 ↗
• MalfunctionFeb 1, 2019Inability to Irrigate; Physical Resistance/Sticking

  IT WAS REPORTED VIA MEDWATCH THAT "AN 18G 4F POWER PICC SOLO CATHETER HAVING DIFFICULTY WITH FLUSHING PICC LINE REMOVED WITH DIFFICULTY. RESISTANCE NOTED AND REQUIRING MUSCLE MASSAGE. DISTAL 5CM OF LINE NOTED TO BE TORTUOUS UPON REMOVAL." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296948 ↗
• InjuryJul 14, 2016Break; Unraveled Material

  ON 06/24/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THE GUIDEWIRE UNRAVELED AND BROKE INSIDE THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL. IT WAS STATED THAT THE PATIENT IS DOING WELL. OF NOTE, THE PATIENT TESTED POSITIVE FOR C-DIFF AFTER THE FACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5797069 ↗