PowerPICC SOLO 1194108D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741155093), received between Jul 12, 2019 and Aug 26, 2026 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2026Open, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Mar 11, 2025Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454721 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  IT WAS REPORTED, PICC LINE WAS PLACED (B)(6) 2025 FOR LTA AND HAD BEEN IN FOR 18 DAYS. PATIENT CAME IN FOR ASSESSMENT OF THE PICC LINE, DRESSING HAD BEEN CHANGED AND THE DRESSING WAS DRY NOTED THAT THERE WAS AROUND 4CM EXTERNAL AND ON INSERTION THERE WAS 0 OUTSIDE THE SKIN. I FLUSHED THE PICC AND FLUID CAME OUT AND SATURATED THE DRESSING. PICC LINE WAS TAKEN DOWN AND NOTED A SPLIT IN THE CATHETER. PICC WAS REMOVED AND A MIDLINE WAS PLACED IN ORDER FOR THE ABX TREATMENT TO BE COMPLETED WHICH WAS TO BE (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24148979 ↗
• MalfunctionSep 10, 2025Material Deformation; Material Deformation

  IT WAS REPORTED PICC NURSE WAS CALLED TO TROUBLESHOOT A PICC LINE THAT WOULDN'T FLUSH OR ASPIRATE. PICC NURSE OBSERVED THAT THE PICC WAS INSERTED ALL THE WAY TO THE HUB, SHE TRIED TO FLUSH AND ASPIRATE WITH NO SUCCESS. SHE PULLED LINE BACK TO THE ZERO MARK AND TRIED TO FLUSH AND ASPIRATE AGAIN. ULTIMATELY, SHE PULLED LINE AS IT WAS PROBLEMATIC. UPON VISUAL INSPECTION, SHE SAW A WHITE MARK LOCATED BETWEEN THE 2 AND 3 CM MARKINGS. DESCRIPTION FROM THE NURSE IS THAT THE POLYURETHANE LOOKS LIKE IT WAS ¿WORN THIN¿. LINE WAS INDWELLING FROM ON (B)(6) 2025. NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION PROVIDED 09/02/2025: SL PICC INSERTED WITH 0CM EXTERNAL, TRIMMED TO 46CM. UPON INITIAL ASSESSMENT, PICC WAS HUBBED. PICC PULLED BACK TO 0CM, FLUSHED AND ASPIRATED WELL. AFTER DRESSING, COULD NOT FLUSH OR ASPIRATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018150 ↗
• MalfunctionAug 18, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY WITH PEELING APART THE PEEL AWAY MICRO INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834194 ↗
• MalfunctionAug 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED CONSULT TO VAST PLACED DUE TO CATHETER "LEAKING". VAST ARRIVED AT BEDSIDE TO ASSESS. PICC LINE FOUND TO BE LEAKING FROM INSERTION SITE. CXR ORDERED. CXR APPEARS TO SHOW LINE PERFORATION AROUND 3CM FROM HUB. SPOKE WITH MIS BARIATRICS TO INFORM OF VAST PLAN OF REMOVAL. PICC REMOVED AT BEDSIDE BY VAST RN, NO COMPLICATIONS, CONFIRMED LINE PERFORATION AT 2.5CM. BEFORE REMOVAL, LEAKING AT SITE NOTED THAT DID NOT RESULT IN PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793687 ↗
• MalfunctionJul 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED (B)(6) 2025 DISCOVERED A FRACTURED PICC. IT WAS PLACED (B)(6) 2025. THE LINE STARTED LEAKING THAT DAY, NO LEAKING NOTED PREVIOUSLY PER DOCUMENTATION AND PATIENT/RN REPORT. WE REMOVED IT AND FOUND THE LEAK AT THE 5 CM MARK AFTER FLUSHING IT. (DEPTH AT SKIN WAS 3 CM SO LEAK WAS NOT AT THE EXTERNAL SECTION OF THE LINE). THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22634767 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PRIMARY RN CALLED FOR PICC LINE PROBLEM. PATIENT WAS AT CARE FACILITY AND WAS READMITTED LAST NIGHT. LINE FLUSHED WITH SALINE, AND WE NOTED LEAKAGE AT INSERTION SITE WITH SOME PAIN AS WELL. FAMILY AT BEDSIDE AND PATIENT MENTIONED TO US THAT "LINE WAS CLOTTED OFF AT CARE FACILITY, AND ATTEMPTS WERE MADE TO UN-CLOT IT. PICC LINE WAS DISCONTINUED, UPON ASSESSMENT OF PICC LINE, PIN SIZE LEAKAGE NOTED BETWEEN THE 4 AND 5 CM MARKING ON LINE. PATIENT HARM: PATIENT STATED HAVING PAIN NEAR INSERTION SITE WHEN CATHETER WAS USED, UNABLE TO ASSESS ANY OTHER HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Infiltration into Tissue; Pain

  MAUDE report 22160982 ↗
• MalfunctionMay 13, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT 3CG SENSOR WAS NOTED TO BE FRACTURED ON REMOVAL. THERE WAS NO IMPACT TO THE PATIENT OR USER. THE COMPONENT INVOLVED WAS THE STYLET. THE FACILITY REPORTS THEY DO NO INSERT THE PICCS WITH TPS AND ROUTINELY REMOVE THE TPS STYLET FOR THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011337 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE WAS A HOLE IN THE PICC AT THE 4CM MARK. PATIENT HAD TO COME INTO HOSPITAL TO REPLACE PICC LINE. THE PATIENT WENT HOME WITH PICC LINE FOR LONG TERM ANTIBIOTICS. THE PATIENT NOTICED LEAKING AT THE INSERTION SITE AND THE PICC LINE HAD TO BE REPLACED WITH A NEW ONE. WHEN THE PICC CATHETER WAS REMOVED, THE IV NURSE FLUSHED THE CATHETER AND NOTICED THAT THERE WAS SALINE FLUSH SQUIRTED OUT ON THE SIDE OF THE CATHETER APPROXIMATELY 4CM FROM THE HUB. THE PATIENT WAS NOT HAPPY WITH GOING TO THE ER AND HAVING TO INCUR A MEDICAL BILL BECAUSE OF THIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961354 ↗
• MalfunctionMay 2, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT THE WIRE CONNECTION FOR THE 3CG WAS DISCONNECTED. NO IMPACT: PATIENT WAS IN A-FIX SO CHEST X-RAY WAS NEEDED ANYWAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955576 ↗
• MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ISSUE REPORTED WITH AN OUTPATIENT PICC LINE. VAT TEAM SPOKE ON THE PHONE WITH THE HOME HEALTH NURSE AS SHE WAS CONCERNED THERE WAS A LEAK IN THE LINE. PATIENT CAME INTO THE ER AND WHEN THE PICC WAS ASSESSED, THERE WAS A SMALL HOLE RIGHT BELOW THE ATTACHMENT FOR THE STATLOCK. VAT TEAM SPOKE WITH THE ER MD AND A DIFFERENT LINE WAS PLACED. PATIENT HAD DELAY IN ANTIBIOTIC TREATMENT BUT WAS ABLE TO BE DISCHARGED HOME TO FINISH HIS ABX COURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905181 ↗
• MalfunctionMar 25, 2025Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  IT WAS REPORTED UPON REMOVING THE INTERNAL PICC WIRE TO TRIM THE WIRE WAS RIDGED AND WOULD NOT PULL OUT SMOOTHLY. PATIENT NEEDED A PICC FOR LONG TERM ABX. 4F SINGLE LUMEN PICC CHOSEN. I WENT TO TRIM THE CATHETER TO 46CM AND THE INTERNAL PICC WIRE WOULD NOT PULL OUT SMOOTHLY IT FELT IT WAS STUCK. I PULLED THE WIRE ALL THE WAY TO INSPECT WIRE AND DID NOT NOTICE ANY MALFORMATIONS OR CONCERN. TRIED TO ADVANCE THE WIRE THRU THE CATHETER AND SAME TIGHTNESS OCCURRED. TRIED TO PULL WIRE BACK ONCE MORE AND IT BARELY BUDGES. I REFLUSHED SALINE THRU AND STILL NO IMPROVEMENT WITH MOVEMENT SO I ABORTED AND OBTAINED A NEW KIT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692632 ↗
• MalfunctionMar 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, HAD A PICC PLACED ON 23RD JANUARY. THEY CAME IN TODAY FOR APPOINTMENT AND THE PICC NURSE WAS NOTIFIED THAT THE PICC WAS SEEPING AROUND THE INSERTION SITE. ANOTHER NURSE WENT TO FLUSH AND IT LEAKED RIGHT OUT SO THEY ENDED UP REMOVING THE PICC AND THERE IS A HOLE THE SIZE 1 CM MARKING. THE PATIENT SAID SHE WAS INFUSING AND THEN SHE HAD BEEN WET SO IT SEEMED TO BE A STEADY LEAK. ADDITIONAL INFORMATION: THERE WAS NO DIRECT PATIENT HARM HOWEVER THE PATIENT DIDN'T PROPERLY RECEIVE HER ANTIBIOTICS FOR SEVERAL DAYS BECAUSE AFTER THE HOLE IN THE LINE, THE MEDICATION WAS COMING BACK OUT AROUND THE INSERTION SITE OF THE PICC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21519996 ↗
• MalfunctionJan 22, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT PROVIDER COULD NOT BREAK THE DILATOR/SHEATH. IT TOOK A GREAT AMOUNT OF STRENGTH TO BREAK IT. NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210337 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FAULTY PICC LINE THAT HAS A SMALL HOLE IN IT. PATIENT SEEN FOR INFUSION THERAPY. PICC LINE WAS PLACED ON (B)(6) 2024. PICC STAFF NOTED NO BLOOD RETURN AND THE PATIENT COMPLAINED OF PAIN AT THE INSERTION SITE. THE PICC LINE WAS REMOVED BY PICC TEAM STAFF ON (B)(6) 2024. THE PATIENT HAD BEEN COMING TO THE INFUSION CENTER STARTING ON (B)(6) 2024. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 20065223 ↗
• MalfunctionAug 23, 2024Component Missing; Component Missing

  IT WAS REPORTED BY THE CUSTOMER WHEN SHE TRIED TO USE THE PICC KIT, THE KIT WAS MISSING THE END CAP FOR THE INTRODUCER (LITTLE WHITE PIECE THAT KEEPS THE BLOOD FROM LEAKING OUT OF THE HOLE). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057195 ↗
• MalfunctionAug 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6), AFTER ACCESSING THE PATIENT VESSEL AND ASSESSING THE VEIN DILATOR BEFORE INSERTING INTO THE PATIENT, IT IS BENT AND ALSO AT THE TIP OF THE DARK GREY IS NOT SMOOTH AND HAD LIKE A BUBBLE IN THE MATERIAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19917737 ↗
• MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THE PLASTIC RETAINER OF STATLOCK IS COMING OFF THE TRICOT PAD. LOSING PICC/ACCESS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695890 ↗
• InjuryJun 16, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY CUSTOMER THAT UPON INSERTING THIS PICC, SOME RESISTANCE WAS FELT SO PICC RN PULLED PICC OUT AND THE GOLD TIP OF THE WIRE CAME OFF AND WAS LODGED IN PATIENT'S TISSUE. PATIENT HAD WIRE IN SOFT TISSUE (NOT VEIN) AND USER COULD NOT PLACE PICC. ADDITIONAL INFO RECEIVED: A VASCULAR SURGEON AND INTERVENTIONAL RADIOLOGIST REVIEWED THE XRAYS AND BOTH STATED THE RISK/BENEFIT ANALYSIS DID NOT JUSTIFY REMOVING THE PIECE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 17146749 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER "POST PICC PROCEDURE WIRE WAS INSPECTED TO HAVE A SIGNIFICANT KINK TOWARD THE LOWER THIRD JUST ABOVE THE TECHNOLOGY PORTION OF THE WIRE. NO DAMAGE WAS NOTICED PRE PROCEDURE AND NOTHING WAS NOTED DURING PLACEMENT TO HAVE CAUSED THE KINK OR FEEL THE WIRE HAD A PROBLEM. TECHNOLOGY WORKED AS INTENDED TO CONFIRM VIA ECG." ADDITIONAL INFORMATION RECEIVED 5 JUNE 2023: IT WAS REPORTED BY THE CUSTOMER "NO HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME OCCURRED. AFTER FOUND OUT THE BEND PICC WIRE, X-RAY WAS REQUESTED TO MAKE SURE THE TIP WAS IN THE APPROPRIATE LOCATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139595 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER "PICC WAS LEAKING, SMALL PIN HOLE NEAR INSERTION SITE." ADDITIONAL INFORMATION FROM CUSTOMER: PICC WAS LEAKING AT INSERTION SITE, AFTER LINE WAS D/C¿D, VAT RN NOTICED A ¿PIN HOLE¿ AT THE LEVEL OF 0. CATHETER WAS SECURED WITH A STATLOCK. LINE WAS REMOVED AND A SECOND PICC WAS INSERTED THE NEXT DAY. PATIENT IS BEING TREATED FOR OSTEOMYELITIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811475 ↗
• MalfunctionJun 10, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED BY THE CUSTOMER " WELL, I JUST DID MY 2ND PICC , UNLESS I GO VERY VERY SLOWLY, THE LOLLYPOP IS LOST. ALSO, I SAW WONKY P-WAVES. LOOKS GOOD, THEN SEVERAL IN A ROW LOOK LIKE THERE IS INTERFERENCE, HUGE DEFLECTIONS, AND THEN IT GOES BACK TO A GOOD READING. . . HAVEN T BEEN ABLE TO RULE OUT A PROBLEM WITH THE NEW STYLETS EITHER. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657806 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "COULD NOT ADVANCE TRIED DOUBLE DILATING BUT STILL COULD NOT ADVANCE. TRIED DOUBLE DILATING SECOND TIME AND BENT TO PIECES. IT BENT 3 DIFFERENT PLACES. GOT A MICROINTRODUCER KIT OUT AND IT WENT IN FINE." ON 8/03/2021 - THE RETURNED SAMPLE EXHIBITED SLIGHT BENDS AND A SPLIT INTRODUCER AND SHEATH. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370847 ↗
• MalfunctionMar 12, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "TEAM OPENED UP THE PICC KIT AND THERE WAS A DRIED BUG ON THE CSR WRAPPING. PRODUCT WAS NEVER UTILIZED ON A PT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473370 ↗
• MalfunctionFeb 9, 2021Break

  IT WAS REPORTED STYLET WIRE ON A PICC WAS BROKEN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11304653 ↗