PowerPICC Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1174118Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741034466), received between Jan 14, 2016 and Sep 24, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (32 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Deformation

  It was reported that the introducer has been observed to buckle during insertion.It was reported this occurred with 2 devices. This report addresses both devices.09/08/2026: During evaluation it was found that a microscopic observation revealed the longitudinal split in the sheath to have sharp fracture edges.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883629 ↗
• InjurySep 10, 2026Material Frayed

  It was reported PICC inserted in (b)(6) 2026 on a child with 3CG. Child was in hospital and found a piece of not sure if stylet or a small piece of PICC in the patient. Additional Information received on 25-AugThe child is currently asymptomatic. An analysis by interventional radiologists and pediatric cardiac surgeons is underway to determine whether it is the best PEC. The PICCLINE was installed on (b)(6) and removed on (b)(6) 2026, but the distal metallic end of the guide is still in the intracardiac position.Additional information received on 28-AugThe PICC was inserted (b)(6) and the metallic fragment was identified on (b)(6).Xrays taken in April and May show the same fragment in the same location.The insertion records indicate the procedure was uncomplicated with no documented issues.P wave guidance was used throughout the procedure and remained functional until the final step, when the guidewire was withdrawn and the PICC was trimmed at approximately 25 centimeters for the 10-year-old patient.The CHU Medical team evaluated three options:Leave the fragment in place and monitor with follow-up imaging in 6 months Surgical removal via sternotomy (considered high risk)Radiologic

  Patient problems: Foreign Body In Patient

  MAUDE report 50714868 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT PICC LINE FLUSHED BY RN PRE CHEMOTHERAPY. FLUSH SOLUTION RETURNED THROUGH PICC INSERTION SITE UNDER PICC DRESSING. PICC LINE REMOVED. CRACK IN LINE OBSERVED AROUND THE 10 CM MARK. TESTED WITH SALINE, AND SALINE SOLUTION LEAKING FROM THE CRACKED AREA ON LINE. NEW PICC LINE TO BE INSERTED NEXT DAY REQUIRING INVASIVE PROCEDURE. CHEMO DELAYED A DAY. RESCHEDULED TO NEXT DAY. PRE MEDICATIONS TO CHEMOTHERAPY WERE ADMINISTERED UNNECESSARILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220067 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKING AT THE DISTAL END. PICC WAS PLACED ON AUG 6. PICC HAD TO BE REMOVED PREMATURELY, NO HARM TO PATIENT, OTHER THAN PUTTING A PATIENT THRU AN UNNECESSARY PICC INSERTION, WHICH LEADS TO THE PATIENT NOT HAVING A GOOD EXPERIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162132 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT HAD THE PICC SINCE (B)(6) 2025 AND GETTING MEDICATION AT HOME AND NOTICED THE PICC WAS LEAKING WHEN FLUSHING. PT WENT TO THE ER REMOVED THE PICC AND REPLACED WITH ANOTHER PICC. IT WAS BROKEN AT THE 9CM MARK WHEN REMOVED. NO SECUREMENT DEVICE, ONLY TEGADERM IV ADVANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019796 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED WE REMOVED A PICC LINE TODAY THAT WAS FOUND TO BE LEAKING AT THE END NEAR THE HARD PURPLE PLASTIC ATTACHMENT THAT WE CONNECT THE NEEDLELESS CONNECTOR. THE LINE HAD TO BE REMOVED BEFORE IT WAS CLINICALLY INDICATED. THE PATIENT THEN NEEDED TO BE SUBJECTED TO ANOTHER INSERTION. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904856 ↗
• MalfunctionFeb 24, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED "WE HAD A PATIENT COME IN THIS MORNING WITH A DEFECT IN HIS PICC LUMEN. IT WAS LEAKING SALINE AND PULLING AIR ON THE EXTERNAL LUMEN WHERE IT MEETS THE HUB WHERE YOU CONNECT THE NEEDLE FREE CONNECTOR. PICC WAS INSERTED BY OUR TEAM ON (B)(6) 2025. THE PATIENT'S WIFE NOTICED LEAKING FROM THE EXTERNAL LUMEN ON FRIDAY ON (B)(6) AND CAME TO ER. PATIENT WAS SENT HOME AND RETURNED THIS AM TO BE ASSESSED BY US. WE DEFERRED TO IR FOR EXCHANGE OVER WIRE FOR NEW PICC. THERE WAS A CLEAR NEEDLELESS CONNECTOR ATTACHED TO THE PICC, THE CONNECTION WAS NOT LOOSE OF THE NEEDLELESS CONNECTOR AND HUB. NO HARM TO PATIENT THAT I AM AWARE OF." NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430784 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED PATIENT'S PICC LINE WAS LEAKING FROM SITE NOTED RUNNING DOWN PATIENTS ARM POST CHEMO. DRESSING WAS REMOVED AND CRACK IN LINE NOTED ABOVE THE WINGS OF PICC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24336574 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED NURSE WENT TO DO A DRESSING CHANGE POST CHEMOTHERAPY. WHEN DRESSING WAS REMOVED NURSE NOTICED PICC LEAKING AT INSERTION SITE - LINE WAS ABLE TO BE FLUSHED WITH GOOD BLOOD RETURN BUT SIGNIFICANT LEAKING NOTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335588 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CLINICIAN WENT TO COMPLETE DRESSING CHANGE DURING 30MIN POST MONITORING AN DURING NORMAL SALINE BOLUS POST CHEMOTHERAPY. CLINICIAN REMOVING DRESSING AND NOTICED LEAKING FROM PICC ONTO ARM. LIGHT PINK LIQUID NOTED ON WHITE TRANSPARENT SECUREMENT DRESSING. THREE DROPS WERE NOTED AND EACH THE SIZE OF A PENCIL ERASER. PATIENT HAD RECEIVED DOXORUBICIN PREVIOUSLY TODAY. CLINICIAN STOPPED INFUSION AND CALLED FOR HELP. NP AND CHARGE NURSE AT BEDSIDE. CLINICIAN FLUSHED LINE. FLUSHED WELL AND GOT BLOOD RETURN. SALINE AND BLOOD NOTED TO LEAK OUT OF LINE. HOLE SEEN IN PICC. PICC PULLED BY NP. PATIENT TOLERATED WELL. THIS CAUSED UNEXPECTED AND PROLONGED CARE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850852 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PATIENT'S MOM CALLED AND SAID PICC LINE WAS LEAKING, FLUID SEEN ON PATIENTS ARM. CYTARABINE CURRENTLY INFUSING. INFUSION PAUSED. LINE WAS FLUSHED WITH BLOOD RETURN BUT THEY DID NOTICE A SMALL AMOUNT OF FLUID ON GLOVE. DRESSING PEELED BACK AND CRACK NOTED ABOVE THE WINGS OF SINGLE LUMEN PICC. LINE CLAMPED ABOVE BREAK AND COVERED WITH CHLORHEXIDINE SWAB AND TEGADERM. CYTARABINE ONLY INFUSED HALF OF BAG. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292196 ↗
• MalfunctionSep 8, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT THEY PROCEEDED TO TRY TO INSERT THE INTRODUCER INTO THE VEIN, BUT AFTER FEELING RESISTANCE I PULLED THE INTRODUCER OUT TO INSPECT IT. I FOUND THAT THE INTRODUCER HAD A SMALL SNAG OF PLASTIC. UPON FURTHER INSPECTION AND ON THE SAME SIDE AS THE LIP, THE SHEATH HAD THE SAME SNAG OF PLASTIC. I HAD MY ASSIST DROP A NEW INTRODUCER KIT, AND I FINISHED THE PROCEDURE WITH NO FURTHER MISHAPS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995135 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER OBSERVED A CRACK AT 0.5 CM FROM THE HUB ON A POWERPICC SINGLE LUMEN 4FR. THIS SMALL CRACK WAS LOCATED OUTSIDE THE PATIENT. PICC WAS IN PLACE FOR 17 DAYS. SECURACATH AND AN IV ADVANCED DRESSING WERE USED AS SECUREMENT DEVICES. PICC WAS REMOVED AND REPLACED BY ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983088 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC INSERTED ON (B)(6) 2025 AND REMOVED ON (B)(6) WAS LEAKING AT THE INSERTION SITE WHEN FLUSHED. THE PICC WAS REMOVED AND FOUND TO HAVE A CATHETER FRACTURE JUST BELOW THE 4 CM MARK. THE PICC HAD BEEN TRIMMED TO 43 CM AND WAS 3 CM EXTERNAL PRIOR TO ITS REMOVAL. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561864 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523222 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523181 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523175 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523171 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522383 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522376 ↗
• MalfunctionJul 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "BUCKLING" WAS OCCURRING QUITE FREQUENTLY, CAUSING THEM TO ADAPT THEIR DILATION TECHNIQUE TO ACCOMMODATE FOR IT (SUCH AS A LARGER NICK IN THE SKIN, STRETCHING AND PAUSING BEFORE CONTINUING, AND HOLDING THE DEVICE MUCH CLOSER TO THE HUB OF THE DILATOR). THERE WAS NO REPORT OF PATIENT HARM. THE EXACT NUMBER OF OCCURRENCES OR DEVICES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522350 ↗
• MalfunctionJul 16, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED LAST WEEK THE CLINICIAN HAD TO REINSERT A NEW PICC FOR A PATIENT AS THEY HAD TO REMOVE THE PATIENT'S SINGLE LUMEN THAT HAD BEEN INSERTED (B)(6) AT ANOTHER FACILITY. IT WAS A SINGLE LUMEN NON-VALVED LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520451 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, WHILE ASSESSING A PATIENT'S NON-VALVED PICC LINE, IT BEGAN TO LEAK SEROUS FLUID ON HER ARM. I EXCHANGED THE PICC AND THERE IS A SMALL HOLE AT THE 10-11CM MARK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512146 ↗
• MalfunctionJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC HAS A CRACK AT THE HUB. PICC HAS A CRACK AT THE HUB. PICC WAS INSERTED (B)(6) 2025 AND REMOVED (B)(6) 2025, DUE TO LEAKING. NO HARM TO THE PATIENT. NURSE WAS GOING TO INFUSE CHEMO BUT STOPPED WHEN NOTICED DRIPPING FROM SITE WITH SALINE FLUSH PRIOR TO CHEMO. ADDITIONAL INFORMATION RECEIVED ON 7/4/2025: A NEW PICC WAS INSERTED AFTER REMOVAL OF THE LEAKING PICC. THIS CAUSED A DELAY IN THE PATIENT RECEIVING HER CHEMOTHERAPY AND EMOTIONAL TRAUMA RELATED TO UNEXPECTEDLY HAVING TO REMOVE HER PICC SHE'S HAD FOR 6 MONTHS AND INSERT A NEW PICC.

  Patient problems: Distress

  MAUDE report 22497797 ↗
• MalfunctionJul 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THE STAFF FLUSHED PICC DURING LINE MAINTENANCE AND NOTED A LEAK. TEAM WENT TO ASSESS AND FOUND LINE WAS TWISTED. WHERE KINK WAS PRESENT IS A LEAK. PICC REMOVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476138 ↗