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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741028595), received between Jan 31, 2019 and Jun 9, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A FRACTURED DEVICE. THE POWER PICC LINE WAS INSERTED INTO ONE OF OUR PATIENTS IN FACILITY. 4FR POWER PICC SOLO SINGLE LUMEN CATHETER. INSERTED INTO RIGHT BRACHIAL VEIN WITHOUT ISSUE. INSERTION DATE (B)(6) 2022 AT FACILITY. REMOVED ON (B)(6) 2022 DUE TO LEAK FROM SECURE-CATH AREA. FRACTURE PRESENT AT 12CM. LINE LENGTH: 45CM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14650644 ↗
• MalfunctionJan 4, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA (B)(4): "PATIENT WITH POWERPICC SOLO (REFERENCE# 9194108. LOT# REDY2960) PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020 ASKING FOR POWERPICC SOLO CATHETER MATERIAL CONTENT STATING SHE HAD A REACTION TO THE CATHETER. CALLER STATES HER DOCTOR REMOVED IT AND THERE WAS A 3" FIBRIN CLOT ON THE END OF THE CATHETER HER DOCTOR SAID MAY BE RELATED TO ALLERGY. CALLER STATES SHE HAS LYME'S DISEASE AND HAS INCREASED FIBRIN ACTIVITY. CALLER STATES SHE DOES NOT THINK THERE WAS A DEVICE PROBLEM BUT THAT SHE REACTED TO THE DEVICE MATERIAL. CALLER ALSO ASKING IN GENERAL FOR MATERIAL CONTENT THAT BARD/BD PORTS ARE MADE OF STATING SHE ASKED HER DOCTOR AND THEY SAID TO CALL MANUFACTURER." (B)(4) RESPONSE: "INFORMED CALLER POWERPICC SOLO IS A POLYURETHANE CATHETER WITH SILICONE VALVES. INFORMED THAT IN GENERAL, BARD/BD PORTS ARE TITANIUM OR PLASTIC WITH SILICONE SEPTUMS AND EITHER A POLYURETHANE CATHETER OR A SILICONE (GROSHONG) CATHETER. EXPLAINED THAT HER HEALTHCARE PROVIDER CAN ALSO CALL AND PROVIDED MY NAME PER REQUEST." ADDITIONAL INFORMATION RECEIVED 12/09/2020: "AS A PATIENT I DO NOT KNOW THE TYPE OF ATTACHMENT PRODUCT THAT WAS USED. I DO KNOW THAT WHEN CHANGED IT CLICKED I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11110699 ↗
• MalfunctionJan 4, 2021Coagulation in Device or Device Ingredient

  IT WAS REPORTED VIA MS&S: "PATIENT WITH POWERPICC SOLO (REFERENCE# (B)(4). LOT# REDY2960) PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020 ASKING FOR POWERPICC SOLO CATHETER MATERIAL CONTENT STATING SHE HAD A REACTION TO THE CATHETER. CALLER STATES HER DOCTOR REMOVED IT AND THERE WAS A 3" FIBRIN CLOT ON THE END OF THE CATHETER HER DOCTOR SAID MAY BE RELATED TO ALLERGY. CALLER STATES SHE HAS LYME'S DISEASE AND HAS INCREASED FIBRIN ACTIVITY. CALLER STATES SHE DOES NOT THINK THERE WAS A DEVICE PROBLEM BUT THAT SHE REACTED TO THE DEVICE MATERIAL. CALLER ALSO ASKING IN GENERAL FOR MATERIAL CONTENT THAT BARD/BD PORTS ARE MADE OF STATING SHE ASKED HER DOCTOR AND THEY SAID TO CALL MANUFACTURER." MS&S RESPONSE: "INFORMED CALLER POWERPICC SOLO IS A POLYURETHANE CATHETER WITH SILICONE VALVES. INFORMED THAT IN GENERAL, BARD/BD PORTS ARE TITANIUM OR PLASTIC WITH SILICONE SEPTUMS AND EITHER A POLYURETHANE CATHETER OR A SILICONE (GROSHONG) CATHETER. EXPLAINED THAT HER HEALTHCARE PROVIDER CAN ALSO CALL AND PROVIDED MY NAME PER REQUEST." ADDITIONAL INFORMATION RECEIVED 12/09/2020: "AS A PATIENT I DO NOT KNOW THE TYPE OF ATTACHMENT PRODUCT THAT WAS USED. I DO KNOW THAT WHEN CHANGED IT /CLICKED IN PL

  Patient problems: Itching Sensation; Rash

  MAUDE report 11109363 ↗
• InjuryFeb 1, 2019Malposition of Device

  IT WAS REPORTED PICC WAS PLACED BY PICC RN AT BEDSIDE, CHEST X-RAY OBTAINED, X-RAY DICTATED TIP OF CATHETER IN INNOMINATE VEIN. PATIENT BROUGHT TO INTERVENTIONAL RADIOLOGY FOR RIGHT SIDED PICC PLACEMENT DUE TO NERVE PAIN AT INSERTION SITE AND MALPOSITION OF PICC. THIS REPORT PERTAINS TO THE NERVE DAMAGE.

  Patient problems: Nerve Damage

  MAUDE report 8297918 ↗
• MalfunctionFeb 1, 2019Malposition of Device

  IT WAS REPORTED PICC WAS PLACED BY PICC RN AT BEDSIDE, CHEST X-RAY OBTAINED, X-RAY DICTATED TIP OF CATHETER IN INNOMINANT VEIN. PATIENT BROUGHT TO INTERVENTIONAL RADIOLOGY FOR RIGHT SIDED PICC PLACEMENT DUE TO NERVE PAIN AT INSERTION SITE AND MALPOSITION OF PICC. THIS REPORT ADDRESS THE MALPOSITION OF THE PICC.

  Patient problems: Foreign Body In Patient

  MAUDE report 8297635 ↗
• InjuryJan 31, 2019Malposition of Device

  IT WAS REPORTED PICC WAS PLACED BY PICC RN AT BEDSIDE, CHEST X-RAY OBTAINED, X-RAY DICTATED TIP OF CATHETER IN INNOMINATE VEIN. PATIENT BROUGHT TO INTERVENTIONAL RADIOLOGY FOR RIGHT SIDED PICC PLACEMENT DUE TO NERVE PAIN AT INSERTION SITE AND MALPOSITION OF PICC. SECOND CHEST X-RAY CONFIRMED FOREIGN OBJECT IN RIGHT VENTRICLE, MEASURING 6CM. CT SCAN PERFORMED IDENTIFYING AS WIRE STYLET. X-RAY ON ADMISSION IN ED CONFIRMED NO METAL OBJECT AT ADMISSION. PATIENT PLACED ON TELEMETRY INDICATING MULTIPLE RUNS OF PVC'S. PICC REMOVED, AND IR PHYSICIAN REMOVED WIRE. WIRE WAS SENT TO PATHOLOGY FOR REVIEW. PATIENT ON TELEMETRY WITH NO ILL EFFECTS. THIS REPORT ADDRESSES THE WIRE FRAGMENT.

  Patient problems: Pain

  MAUDE report 8295255 ↗