PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1396118Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034770), received between Aug 31, 2017 and Jul 5, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS NOTED TO BE LEAKING ON FLUSHING ON THE 11/6 FROM A CRACK IN THE GREY LUMEN DURING AN ALS. COVERED WITH OPSITE TO SEAL, AND MEDICAL DECISION TO LEAVE INSITU AS VERY DIFFICULT ACCESS AND ONGOING HEMODYNAMIC INSTABILITY. REMOVED ON THE (B)(6) AND MIDLINE INSERTED. ON INSPECTION LOOKS LIKE SOMEONE HAS EITHER OVERTIGHTENED A CONNECTOR, OR USED FORCEPS TO REMOVE MAYBE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664096 ↗
• InjuryFeb 9, 2018Patient-Device Incompatibility

  IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD PICC PLACED ON (B)(6) 2017, AND WAS REMOVED ON (B)(6) 2017, DUE TO A BLOOD CLOT AND BREAK DOWN OF THE SKIN. IT WAS STATED THAT THE PATIENT MAY BE REACTING TO THE MATERIAL IN THE LINE. A NEW PICC WAS PLACED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 7260469 ↗
• MalfunctionAug 31, 2017Break; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED ON 08/09/2017 THAT WHEN THE WHITE LUMEN WAS FLUSHED IT LEAKED SALINE. THE LEFT CONNECTOR WAS REPLACED, BUT WHEN FLUSHED AGAIN, THE SAME ISSUE OCCURRED. THE CONNECTOR WAS REMOVED AND THE VALVE WAS REPORTEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY. 08/25/2017- PER FACILITY REPORT, PICC CATHETER LEAKING AND DISINTEGRATED/CRACKED AT THE PROXIMAL VALVE. LINE UNUSABLE. PICC REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836200 ↗