PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1194108Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741034503), received between Nov 30, 2015 and May 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Activation Problem

  NEEDLE DID NOT SAFETY APPROPRIATELY. GREEN SAFETY DEVICE ON NEEDLE SLID OFF THE END OF THE NEEDLE INSTEAD OF LOCKING IN PLACE, LEAVING THE NEEDLE TIP EXPOSED. NO PHYSICAL HARM OCCURRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107973 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH "CATHETER FRACTURE AT THE 13CM MARK FROM THE HUB, WITHIN THE VESSEL." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050096 ↗
• MalfunctionApr 23, 2021Corroded; Corroded

  IT WAS REPORTED VIA PHONE CALL "THE PICC LINE RN WAS ABOUT TO DO A PROCEDURE, AND FOUND OUT THAT THE CATHETER WAS RUSTED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721115 ↗
• MalfunctionApr 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2020 NURSE PLACED POWERPICC SOLO. WHEN ATTEMPTING TO INSERT THE INTRODUCER INTO THE PATIENT¿S ARM, INTENSE RESISTANCE WAS MET. WHILE TROUBLE SHOOTING THE RESISTANCE SHE PULLED THE INTRODUCER TIP OUT OF THE PATIENT (STILL THREADED OVER THE GUIDEWIRE). INSPECTION OF INTRODUCER AND STYLET AND OUTER SHEATH FOUND THE LEADING EDGE HAD AN IRREGULAR, THICKENED HARD LITTLE KNOT OF PLASTIC. NURSE ATTEMPTED TO SMOOTH WITH GLOVED HAD WAS MADE, BUT WAS UNSUCCESSFUL. A SECOND KIT WAS OPENED AND THE INTRODUCER WAS USED TO SUCCESSFULLY PLACE THE PICC. PATIENT EXPERIENCED A MILD PANIC ATTACH, ANXIETY, AND AGITATION DURING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9984213 ↗
• MalfunctionMar 13, 2019Leak/Splash; Component Missing

  IT WAS REPORTED PICC RN OBSERVED LEAKING FROM THE PICC INSERTION SITE. IT WAS REPORTED THE CLINICIAN PULLED THE CATHETER AND COULD SEE THAT IT HAD SPLIT OPEN AROUND THE 7CM MARK. ALSO REPORTED THAT THE 8CM MARK WAS MISSING/ NOT VISIBLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8418581 ↗
• MalfunctionNov 10, 2017Material Frayed

  FACILITY REPORTED THAT THE WIRE ON SHERLOCK 3CG IS FRAYED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7023090 ↗
• MalfunctionNov 30, 2015Retraction Problem; Unraveled Material; Failure to Advance

  (B)(6) 2015 - THE EXPERT NURSE ACCESSED THE BASILIC VEIN WITHOUT DIFFICULTY. SHE THREADED THE GUIDEWIRE JUST PAST THE NEEDLE, REMOVED THE NEEDLE AND ATTEMPTED TO ADVANCE THE GUIDEWIRE A BIT MORE. IT ALLEGEDLY WOULD NOT ADVANCE. WHEN RESISTANCE WAS MET IT REPORTEDLY "PUSHED ITSELF OUT OF THE VESSEL." THE NURSE WAS NOT COMFORTABLE TO DILATE AND ATTEMPTED TO REMOVE THE GUIDEWIRE. IT WAS SAID TO HAVE FELT "STUCK" ON THE VESSEL AND SUPPOSEDLY UNRAVELED AS SHE PULLED THE GUIDEWIRE OUT OF THE VESSEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5255846 ↗