PowerPICC® SV Catheter with Sherlock Tip Location System (TLS) Stylet 9274108Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741028625), received between Oct 20, 2016 and Dec 2, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING OUR DAILY SAFETY CALL, STAFF REPORTED A CRACKED LUMEN ON THIS DEVICE. THE PICC LINE WAS RE-WIRED ON (B)(6) 2025 DURING A CATH LAB PROCEDURE. THE LINE DID NOT LAST A FULL MONTH BEFORE THE LUMEN WAS FOUND TO BE CRACKED. THERE WAS NO HARM REPORTED, BUT THE PATIENT HAD AN INFECTION, SO THE MEDICAL TEAM THOUGHT IT WAS BEST TO REPLACE THE PICC TO MAKE SURE IT WASN¿T THE SOURCE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23698350 ↗
• InjuryNov 21, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY MEDWATCH PICC LINE WAS INSERTED INTO PATIENT AFTER SELECTION OF BASILIC VEIN. SUBSEQUENT IMAGING REVEALED A METALLIC DENSITY AS A PROBABLE PORTION OF WIRE THAT EXTENDED FROM THE REGION OF THE LEFT PULMONARY ARTERY INTO THE LEFT LOWER LOBE. THE PATIENT UNDERWENT A RIGHT HEART CATH AND THE METAL WAS SUCCESSFULLY REMOVED IN TWO PIECES. A 4 CM FRAGMENT WAS REMOVED FROM THE LEFT PULMONARY ARTERY. A 1 CM FRAGMENT WAS REMOVED FROM THE INFERIOR VENA CAVA. THE FRAGMENTS WERE DESCRIBED AS THIN, BLACK, SOFT WIRE-LIKE MATERIAL REPORTEDLY MATCHING THE STYLET THAT ACCOMPANIES POWER PICC KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23620833 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC BROKEN WHILE IN PATIENT. THERE IS A HOLE ON CATHETER ABOVE WINGS AT INSERTION SITE. PICC RN WAS CHANGING PICC DRESSING WHEN BLEEDING WAS NOTED DURING DRESSING CHANGE. PICC RN NOTICED HOLE IN CATHETER AT THIS POINT AND PATIENT WAS SCHEDULED FOR PICC EXCHANGE. PATIENT TO UNDERGO SECONDARY PROCEDURE FOR PICC EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306849 ↗
• MalfunctionMay 24, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT PICC BROKE AT THE SUTURE WING. HAD TO INSERT ANOTHER PICC. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17000067 ↗
• MalfunctionDec 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT ¿WE HAD A BARD PEDS PICC IN A (B)(6) YEAR OLD PATIENT WHO CAME IN AND DEVELOPED A LEAK IN HER PICC LINE. DUAL LUMEN PICC WAS OUT 3 CM, LEAK WAS FROM THE RED POWER INJECTABLE LINE AT THE POINT OF ABOUT 4 CM. A SECUREACATH WAS HOLDING THE LINE IN PLACE. WE ARE UNSURE IF THE LINE BLEW OR WAS CUT BUT THE LEAK IS AT THE POINT WHERE THE SECURACATH TIP UNDER THE SKIN IS IN THE PATIENT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16071064 ↗
• InjuryJan 14, 2021Material Twisted/Bent

  IT WAS REPORTED "HAD A ISSUE WITH A WIRE IN A PICC KIT. CUSTOMER FELT LIKE THE WIRE MALFUNCTIONED." ADDITIONAL INFORMATION RECEIVED 12/23/2020: "FEMORAL PICC PLACEMENT LINE WENT FROM R FEMORAL CURLED DOWN INTO LEFT AND BACK ON ITSELF, NOTED ON XRAY TO HAVE SHERLOCK WIRE LEFT APPROXIMATELY 3 CM IN LENGTH IN PATIENT" "WAS THERE PATIENT HARM REPORTED?: WIRE FRAGMENT, REMOVED IN IR SAME DAY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171596 ↗
• MalfunctionDec 11, 2020Fluid/Blood Leak

  IT WAS REPORTED THAT WETNESS WAS OBSERVED (B)(6) 2020 WITH NO EVIDENCE OF LEAKING DURING DRESSING CHANGE. IT WAS STATED IT WAS "DAMP" FROM (B)(6) 2020 WHEN NURSES DETERMINED IT WAS "WET" ENOUGH FOR A DRESSING CHANGE AT WHICH TIME THE NURSES OBSERVED THE TPN/LIPIDS LEAKING FROM THE RED LUMEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10993250 ↗
• MalfunctionJan 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POLYURETHANE APPEARED TO BE TORN AT THE SUTURE WINGS. IT CAUSED THE PICC TO LEAK AND THE DRESSING WAS SOILED A DAY AFTER THE DRESSING WAS CHANGED AND THAT IS HOW IT WAS NOTED TO BE LEAKING. THEY HAD PREVIOUSLY REPORTED AN OCCLUSION AND HAD TREATED IT FOR THAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655439 ↗
• MalfunctionApr 23, 2018Crack; Leak/Splash

  THE FACILITY REPORTED TO THE SALES REP THAT A PATIENT'S CATHETER BEGAN TO LEAK FROM A CRACK AT THE HUB. THE CATHETER WAS REMOVED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450678 ↗
• MalfunctionNov 8, 2016Material Frayed; Knotted; Uncoiled

  BAS ENGINEERS FOUND THAT THE GUIDEWIRE RETURNED WAS FRAYED. ON 10/20/2016 - ADDITIONAL INFORMATION WAS RECEIVED ON THE DAMAGED GUIDEWIRE. THE FACILITY REPORTS THEY HAVE HAD SEVERAL EVENTS OF THE GUIDEWIRE KNOTTING OR UNCOILING. THEY SUSPECT THE REASON FOR THIS IS DUE TO ADVANCING OR MANEUVERING THE WIRE WHEN NOT "FLUIDLY SLIDING INTO VESSEL AND THEN TRYING TO PULL BACK ON THE WIRE AGAINST THE STIFF NEEDLE". ALL THE EVENTS OCCURRED WITH THE LONG NEEDLE THAT COMES IN THE KIT, NOT THE "THREAD-OFF CATHETER NEEDLE".

  Patient problems: No Information

  MAUDE report 6085465 ↗
• MalfunctionOct 20, 2016Material Rupture; Improper or Incorrect Procedure or Method

  PER SALES REPRESENTATIVE, A FACILITY REPORTED THAT A PICC RUPTURED. ON 09/26/2016 - ADDITIONAL INFORMATION RECEIVED: SALES REPRESENTATIVE REPORTED THAT THE RUPTURE WAS SUBCUTANEOUS AND THAT THE CLINICIAN USED A 3ML SYRINGE INSTEAD OF A 10ML SYRINGE. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6045288 ↗