PowerPICC SOLO2 Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet 1194118Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00801741034527), received between Nov 13, 2015 and Jun 19, 2026 — classified as 5 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (52 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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT HAD A BARD POWER PICC SOLO THAT WAS INSERTED ON (B)(6) 2025. ASKED TO ASSESS PICC THAT WAS LEAKING. NOTED THAT AT THE 8CM MARK OF PICC THERE WAS A SMALL HOLE IN CATHETER WHERE BLOOD AND FLUID WERE LEAKING. THE PICC HAD BEEN INSERTED WITH 12CM EXTERNAL SO THIS DAMAGE WAS NOTED OUTSIDE OF THE PATIENT APPROXIMATELY 1 CM DISTAL TO THE END OF THE SECURACATH. THE DRESSING HAD NOT BEEN APPLIED APPROPRIATELY SO MOST OF THE EXTERNAL LENGTH OF THE CATHETER WAS EXPOSED OUTSIDE OF THE DRESSING. THE PICC WAS REMOVED. PATIENT REQUIRING ONE MORE WEEK OF IV SO WILL HAVE TO CONTINUE WITH PERIPHERAL IV. NO APPARENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561608 ↗
• MalfunctionJun 16, 2026Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT WHEN THEY WENT TO CHANGE PT'S PICC DRSG AND CAPS, AFTER REMOVING DRESSING, TUBING APPEARED TO HAVE A KINK 8MM UNDER THE SECURACATH BETWEEN THE SECURACATH AND THE LUER LOCK. PT DESCRIBES HIS PICC AS VERY "POSITIONAL" AND STATES THAT WHEN HE WENT DOWN FOR A CT SCAN A WHILE AGO THE LINE STARTED LEAKING WHEN THE TEAM WAS PUSHING CONTRAST. CUSTOMER ATTEMPTED TO STRAIGHTEN KINK USING STERILE TECHNIQUE PRIOR TO CLEANING IN ORDER TO RESOLVE RESISTANCE THAT MAY HAVE BEEN POSITIONAL OR DUE TO KINK IN LINE. KINK STRAIGHTENED - DRSG CHANGE AND CAPS COMPLETED. FLUSHED LINE WITH BLOOD RETURN AND SOME SALINE SOLUTION APPEARED TO LEAK AROUND KINK SITE. PRESSED DRESSING FIRMER AROUND LINE AND LEAKAGE STOPPED - FLUSHING WELL WITH BLOOD RETURN. CUSTOMER REVISITED PT WITH BUDDY NURSE TO REASSESS LINE AND ATTEMPT FLUSHING AGAIN. LEAKAGE ALL AROUND LINE. DOCTOR PAGED AND ORDER PUT IN FOR PICC REMOVAL. PT HESITANT TO REMOVE LINE AS HE REQUIRES ANTI-EMETICS BUT CUSTOMER EXPLAINED THAT LEAKAGE IS AN INFECTION HAZARD AND THERE IS THE POTENTIAL FOR AIR RE-ENTRY WHICH IS A CONCERN. PT AGREEABLE TO LINE REMOVAL AND TO PIV INSERTION FOR PRN MEDICATIONS. PICC REMOVED AT 1440H. PT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524209 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT REMOVAL OF PICC IN MSE DUE TO COMPLAINT OF PAIN DURING INFUSION OF MEDICATION. AFTER REMOVAL, WHEN INJECTING SF 0.9% INTO THE CATHETER, A HOLE WAS OBSERVED IN THE STRUCTURE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 25044827 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED, SLIT IN 4FR PICC LINE AT THE 7 CM MARK. ADDITIONAL INFORMATION PROVIDED 17-MAR-2026: NO HARM WAS DONE TO THE PATIENT. ONCOLOGY NOTED THE LEAKING WHEN THEY STARTED GIVING THE PATIENT A NS BOLUS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706270 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED, SPLIT IN PICC LINE AT THE 1.5CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706269 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CRACK NOTED AT 3.5CM FROM INSERTION SITE. ADDITIONAL INFORMATION RECEIVED 8-DEC-2025: THE CRACK WAS NOTED AFTER THE INFUSER BOTTLE WAS REMOVED. THE INFUSION DIDN¿T LEAK BUT THE CATHETER LEAKED WHEN FLUSHED. THERE WAS A PARTIAL SUBCUTANEOUS CRACK IN THE CATHETER. THIS DID NOT RESULT IN A DELAY IN TREATMENT AND DID NOT INVOLVE AN URGENT OR LIFE-THREATENING MEDICAL SITUATION. CATHETER WAS REMOVED AND A NEW CATHETER PLACED. ORIGINAL CATHETER SECURED WITH SECURACATH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830279 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON ARRIVAL CLIENT STATED THAT SHE THINKS THAT THE PICC HAS "COME OUT". SHE STATED THAT SHE CALLED LAST NIGHT AND HAD SOMEONE COME CHANGE THE DRESSING BECAUSE THERE WAS A LOT OF BLOOD, BUT AS PER PREVIOUS NOTES THERE WAS NO STABILIZATION DEVICE AVAILABLE, SO IT WAS LEFT ON AND JUST THE TEGADERM WAS CHANGED. ON ASSESSMENT NOTED THAT THE PICC LINE HAD MIGRATED OUT ABOUT 6 CM, AND THE STABILIZATION DEVICE WAS DISLODGED AND WRAPPED IN THE TEGADERM. ON PREVIOUS DOCUMENTATION OF PICC IT WAS NOTED TO BE AT THE 1 CM MARK. PICC IS LESS THAN 1 WEEK OLD. ENCOURAGED CLIENT TO GO TO THE HOSPITAL FOR THE SAME, CLIENT AGREED TO SAME. PICC WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767388 ↗
• MalfunctionNov 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED 10/31: CATHETER WAS SECURED WITH 4FR SECURACATH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543911 ↗
• MalfunctionOct 15, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED ON 09/16, DURING A PICC CATHETER INSERTION PROCEDURE INVOLVING THE PATIENT IN QUESTION, THERE WAS A NON-COMPLIANCE WITH THE PART CALLED ¿DILATOR,¿ WHICH CAUSED A SIGNIFICANT FAILURE IN THE PROCEDURE, FORCING THE TEAM TO SUSPEND IT. THE PROBLEM OCCURRED IN THE LAST STAGE OF THE CATHETER INSTALLATION PROCESS, WHICH WAS ALREADY IN PLACE AND STABILIZED WITH GOOD FLOW AND REFLUX, AFTER THE X-RAY WAS PERFORMED, AT THE MOMENT WHEN THE DILATOR IS BROKEN IN HALF FOR REMOVAL. DURING COMPRESSION OF THE BLADES, ONE OF THEM WAS FRACTURED, FORMING A SMALL LOOP THAT WRAPPED AROUND THE CATHETER AND COMPRESSED IT VIOLENTLY, CAUSING A BEND IN THE DEVICE. TEAM MEMBERS ATTEMPTED TO RESCUE THE CATHETER BY CUTTING THE LOOP, BUT IT WAS ALREADY DAMAGED AND PRESENTED CONSIDERABLE RESISTANCE TO INFUSION. BY CONSENSUS, THE TEAM OPTED TO REMOVE IT AND RESCHEDULE THE INSTALLATION OF A NEW DEVICE AT A LATER DATE. UNFORTUNATELY, THE PATIENT HAD TO UNDERGO DIFFICULT VENIPUNCTURES TO CONDUCT THE PRESCRIBED THERAPY. THERE WAS NO DIRECT OR SERIOUS HARM TO THE PATIENT, BUT THERE WAS HARM RESULTING FROM THE FAILURE OF THE PROCEDURE. THERE WAS NO PROLONGED HOSPITALIZATION OR NEED FOR CHANGES IN THE THER

  Patient problems: Unspecified Vascular Problem

  MAUDE report 23292500 ↗
• MalfunctionOct 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT HAS BEEN USING A CATHETER FOR 1 YEAR. WHEN PERFORMING MAINTENANCE ON THE CATHETER, THERE WAS AN OVERFLOW OF SOLUTION AROUND THE CATHETER. WHEN CHECKING THE CATHETER, A 1.5 CM TEAR WAS FOUND IN THE CATHETER INSIDE THE PATIENT'S ARM. PICC CATHETER INSERTION LOCATED IN MSD. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246571 ↗
• MalfunctionAug 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PICC LEAKING ABOUT 4CM FROM INSERTION SITE. PICC LINE REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855549 ↗
• MalfunctionJul 30, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED ONCOLOGY UNABLE TO FLUSH PICC. XRAY DONE WHICH SHOWED PINCHING/WEAK SPOT AT THE 7CM MARK. PICC LINE WAS IN FOR 1 DAY PRIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22670632 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, SPLIT IN PICC TUBING. ADDITIONAL INFORMATION PROVIDED: THE CRACK WAS DISCOVERED BY THE ONCOLOGY NURSES LAST WEEK. THEY WERE UNABLE TO FLUSH IT, GOT AN X-RAY AND COULD SEE THE CRACK IN PATIENT'S ARM AND ENDED UP PULLING IT. THERE WAS NO PATIENT HARM DONE. WE REINSERTED ANOTHER PICC INTO PATIENT ON JULY 2ND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510954 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS FOUND TO BE LEAKING. PICC INSERTED JUNE 17TH, FIRST TIME USED IN ONCOLOGY JUNE 24TH FOUND TO BE LEAKING, PICC REMOVED, SPLIT FOUND IN LINE AT 7CM MARK WITH SLIGHT INDENT AT CRACK SITE, PICC HAD 3CM EXTERNAL LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487641 ↗
• InjuryJul 11, 2025Break; Break

  IT WAS REPORTED, CATHETER FRACTURE, AT HOME. PATIENT USING POWER PICC N. 4 FR MONOLUMEM, SINCE (B)(6) 2024. AFTER THE LAST DOSE OF ANTIBIOTICS (B)(6), A HOME CARE PROFESSIONAL WENT TO REMOVE THE CATHETER AND DURING THE PROCEDURE THE CATHETER SHOWED RESISTANCE AND THEN FRACTURED. ADDITIONAL INFORMATION: CATHETER FRACTURED DURING REMOVAL (IN HOME CARE). CLIENT WAS REFERRED TO THE CC FOR REMOVAL OF THE DEVICE. COMPLETE RUPTURE IN 2 PARTS. THE PROXIMAL PART OF THE CATHETER WAS REMOVED. WHAT STUCK IN THE MSE WAS THE DISTAL PART. NO SYMPTOMS/COMPLICATIONS/DELAY IN TREATMENT. NEW CATHETER NOT INSERTED.

  Patient problems: Distress; Foreign Body In Patient

  MAUDE report 22480869 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT A CHILD UNDERWENT PICC CATHETER PLACEMENT ON MAY 12 FOR ANTIBIOTIC THERAPY IN THE PICU. CATHETER CONTROL X-RAY DID NOT SHOW ANY OBJECTS (PARTIALLY COVERED BY ELECTRODE). ON THE X-RAY TAKEN ON (B)(6) FOR DISCHARGE CONTROL, AN OBJECT WAS IDENTIFIED. VENOUS CATHETERIZATION WAS PERFORMED ON (B)(6) FOR REMOVAL. THE PROCEDURE WAS UNEVENTFUL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320766 ↗
• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION: PATIENT UNABLE TO RECEIVE DOSE OF ANTIBIOTICS DUE TO WHAT WE THOUGHT WAS LEAKING. PATIENT THEN HAD TO HAVE PICC LINE REMOVED, SHE IS A DIFFICULT INSERTION AND HAS TO DRIVE 2 HRS TO HAVE PICC REINSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311363 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, CRACKED PICC NOTED BY PICC NURSE. PICC REMOVED. PICC WAS INSERTED AT ANOTHER FACILITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204055 ↗
• InjuryJun 10, 2025Material Frayed; Material Frayed

  IT WAS REPORTED, CATHETER WAS INSERTED INTO A PEDIATRIC PATIENT ON (B)(6), AND TODAY, DURING A ROUTINE X-RAY, A FOREIGN OBJECT WAS IDENTIFIED IN THE HEART CHAMBER. THE CHILD WILL UNDERGO CATHETERIZATION THIS AFTERNOON, A CARDIAC CATHETERIZATION WILL BE PERFORMED FOR REMOVAL. PATIENT IS CURRENTLY STABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22178163 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC WAS INSERTED ON (B)(6) 2025, PRESENTED RESISTANCE ON (B)(6) 2025 DURING INFUSION OF MEDICATION AND AT THE END THERE WAS LEAKAGE OF MEDICATION THROUGH THE PICC INSERTION OSTIUM (ACCORDING TO REPORT SENT BY EXTERNAL SERVICE). ON (B)(6) 2025, THE MEDICATION WAS ADMINISTERED BY DIRECT INTRAVENOUS INFUSION BY A TEAM FROM THE SAME SERVICE. ON (B)(6) 2025, THE PATIENT WENT TO THE IOT HD FOR ASSESSMENT AND MANAGEMENT, WHERE A HOLE WAS FOUND IN THE BODY OF THE CATHETER AND THE PICC WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997721 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED POWERPICC MONO-LUMEN CATHETER IN THE MIDDLE THIRD OF THE INTERNAL PHASE OF THE MSD POSITIONED IN BASILICA D, SHOWED SIGNIFICANT LEAKING AT THE TIME OF SALINIZATION WITH SF0.9% 10 ML, I.E. CATHETER SHOWING RUPTURE AND IT WAS NECESSARY TO REMOVE CATHETER AND INSERT NEW DEVICE. PATIENT IS BEING FOLLOWED UP BY THE EXTERNAL SUPPORT NETWORK, THEY WERE SPOKEN TO ABOUT HOW TO HANDLE THE CATHETER AND WHETHER THEY WERE FOLLOWING THE RECOMMENDATIONS ESTABLISHED FOR PERMEABILITY AND PROPER FUNCTIONING OF THE CATHETER, AND PATIENT WAS WELL ORIENTED AND AWARE OF DAILY CARE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO EXPOSURE TO BLOOD OR BODILY FLUIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973592 ↗
• MalfunctionApr 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PICC NURSE WAS CALLED TO THE CANCER CLINIC AS THE CHEMO NURSE WAS ASSESSING THE PICC LINE AND NOTICED LEAKING FROM THE SITE. PICC HAD TO BE REMOVED AND PICC NURSE NOTICED A HOLE/FRACTURE AT THE 8CM MARK. THERE WAS NO HARM TO PATIENT AS IT WAS DISCOVERED AT SALINE FLUSH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915642 ↗
• InjuryMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THROMBOPHLEBITIS: THE PATIENT SHOWED SIGNS OF THROMBOPHLEBITIS IN THE BASILIC VEIN, WHICH CAN CAUSE PAIN, EDEMA AND INFLAMMATION, REQUIRING MEDICAL INTERVENTION AND ANTICOAGULATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain; Skin Inflammation/ Irritation; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 21644274 ↗
• MalfunctionMar 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER BEDSIDE NURSE FOUND PICC TO BE LEAKING, PICC REMOVED BUT NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574486 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT PICC LINE CRACKED AT 6CM MARK ALONG WITH THE 3CM INSIDE THE PATIENT. THE PICC LINE LEAKING AT INSERTION SITE WHEN FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527945 ↗