PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9194108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741035609), received between Aug 10, 2017 and Jun 4, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

• MalfunctionJun 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE IS A FRACTURE PRESENT AFTER THE 3CM MARK. NO PATIENT HARM, FRACTURE NOTED BEFORE IT REACHED THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146764 ↗
• MalfunctionAug 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC HAD PIN HOLE FRACTURES NEAR THE 4 CM MARK AS THE LINE WAS LEAKING AS YOU INJECT SALINE. THE CUSTOMER STATED THIS HAS OCCURRED MULTIPLE TIMES HOWEVER AN EXACT QUANTITY WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091381 ↗
• MalfunctionAug 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PICC HAD PIN HOLE FRACTURES NEAR THE 4 CM MARK AS THE LINE WAS LEAKING AS YOU INJECT SALINE. LINE HAD BEEN IN PLACE FOR 1 MONTH. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED, "WHEN YOU FLUSH THE PICC LINE, FLUID APPEARS UNDER THE TEGADERM SITE. THE DRESSING WAS CHANGED, NO KINKS AT THE ENTRY AND THEREFORE THE DECISION WAS TO PLACE ANOTHER LINE ON THE OPPOSITE ARM. THIS PATIENT NEEDED THE PICC LINE FOR SEVERAL MORE WEEKS OF ANTIBIOTIC TREATMENT. ONCE APPROVED, THE REMOVAL OF THE EXISTING PICC IS REMOVED AND NOTED THAT THERE IS A PINHOLE ALONG THE LINE WHERE FLUID LEAKS OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057175 ↗
• MalfunctionJun 5, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY THE CUSTOMER, A LONG BLACK HAIR ON TOP OF THE BLUE DRAPE. ADDITIONAL INFORMATION RECEIVED 5/23/2024: IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT AS IT WAS NOTICED RIGHT AWAY AND NOT USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468728 ↗
• MalfunctionMay 14, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED CUSTOMER OPENED THE TRAY AND THE FILTER STRAY FOR THE LIDOCAINE HAD SOME TYPE OF BROWN/BLACK GOOP INSIDE THE FILTER STRAW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826258 ↗
• MalfunctionJul 17, 2020Material Frayed; Material Frayed

  IT WAS REPORTED VIA MS&S: "CURRENTLY PURCHASE PRODUCT 9194108D, 4FR PICC LINE SINGLE LUMEN, FROM YOU. TODAY I WAS PLACING A PICC LINE ON 355 AND I WAS ABLE TO INSERT THE T-ADAPTOR AND I ADVANCED THE {ICC LINE CATH 20CM AND WAS NOT ABLE TO ADVANCED ANY MORE. I PULLED OUT THE CATH LINE AND WHEN I PULLED THE T ADAPTOR THE TIP WAS MISSING. I HAD TO ORDER CXR AND CT OF THE CHEST TO SEE IF THE TIP WAS LEFT IN THE ARM OR LUNGS. DR. WAS NOT ABLE TO SEE IT IN THE IMAGES. I DON'T KNOW IF THIS IS A MECHANICAL PROBLEM FROM THE KITS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290909 ↗
• MalfunctionSep 13, 2018Unraveled Material

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME UNRAVELED DURING PLACEMENT. INSERTER MET INSERTION WHEN THREADING THROUGH THE INTRODUCER NEEDLE. IT WAS STATED THE RN WENT TO REMOVE THE WIRE AND IT CAME THROUGH THE INTRODUCER NEEDLE SHEERED. NO PATIENT HARM OCCURRED DURING THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7873871 ↗
• InjuryFeb 9, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING INSERTION OF A PICC, THE GUIDEWIRE BROKE AND WAS FOUND IN THE SUBCLAVIAN VEIN. THE PATIENT WAS TAKEN TO SURGERY AND THE WIRE WAS REMOVED BY A VASCULAR SURGEON. IT WAS STATED THE WIRE WAS ABOUT 3¿ IN LENGTH. IT WAS LATER REPORTED THAT THE NURSE THOUGHT IT MAY BE FROM AN OLD PICC PLACEMENT.

  Patient problems: No Code Available

  MAUDE report 7259639 ↗
• InjuryOct 5, 2017Patient-Device Incompatibility

  PER MEDWATCH- REPORT STATED "PATIENT DEVELOPED HIVES, SHORTNESS OF BREATH, WHEEZING, ITCHING, ORAL SWELLING AND ELEVATED BLOOD PRESSURE FOLLOWING INSERTION OF POWERPICC SOLO CATHETER."

  Patient problems: Dyspnea; High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Itching Sensation; Swelling

  MAUDE report 6917641 ↗
• MalfunctionAug 10, 2017Failure to Advance

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP), WAS UNABLE TO THREAD THE CATHETER PAST THE SHOULDER AND DEVICE WAS REMOVED. THE PICC LINE WAS CLEANSED OF BLOOD AND LUMEN FLUSHED. AFTER FLUSHING PICC LINE WITH NORMAL SALINE HCP NOTICED A 1 INCH PIECE OF TISSUE. UPON FURTHER EXAMINATION, HCP NOTED IT TO BE THE COPPER TIP OF THE WIRE. WIRE WAS REMOVED FROM PICC LINE AND EXAMINED. ENTIRE LENGTH WAS ACCOUNTED FOR; CLEAN PICC ADVANCED EASILY INTO CEPHALIC VEIN. PATIENT TOLERATED PROCEDURE WITHOUT COMPLICATIONS. PATIENT HAD NO INDICATION OF ANY POTENTIAL RISK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6786661 ↗