PowerPICC SOLO 1194108D3Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741154997), received between May 15, 2019 and May 12, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PICC TEAM OPENED A POWERPICC SOLO KIT AND THERE WAS A HAIR UNDERNEATH THE TRAY. THE KIT WAS NOT USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25154227 ↗
• MalfunctionJan 16, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHILE INSERTING A PICC, NOTICED THAT THERE WAS A HAIR IN THE KIT. PLACER GOT A NEW PICC TO INSERT DUE TO STERILITY CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093050 ↗
• MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT; LINE RUPTURED AT APPROX. 5 CM MARK. UNABLE TO ADMINISTER THERAPY, REMOVED AND REPLACED THE PICC LINE WAS INSERTED ON (B)(6) 2024, AND ON REMOVED (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505159 ↗
• MalfunctionJan 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD PICC LINE PLACED FOR OUTPATIENT ABX ON 12/2 AND RETURNED TO THE ED WITH SUBCUTANEOUS LEAKING PICC LINE. ON REMOVAL OF THE LUE PICC A LARGE FRACTURE WAS NOTED IN THE PICC LINE AT THE 5 CM MARK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211227 ↗
• MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT PATIENT CAME IN WITH A SL PICC PLACED ON 7/22. THE PICC WAS OUT 2.5 CM ON ARRIVAL. WHEN FLUSHING, SALINE CAME OUT THE INSERTION SITE. ON REMOVAL, PICC WAS SLIT AT THE 4CM MARK. PATIENT DENIES ANY DAMAGE TO THE CATHETER OR ISSUES WITH FLUSHING PREVIOUSLY. VERY SIMILAR SYMPTOMS TO THE OTHER PICC WE HAD WITH THIS PROBLEM. PICC IS NOT IN THE SAME LOT #. SLIT WAS 1-1.5CM BENEATH THE SKIN. THE IMPACT TO THE PATIENT WAS MILD SWELLING TO ARM AND HAVING TO HAVE A NEW PICC LINE PLACED (UNNECESSARY PROCEDURE.

  Patient problems: Swelling/ Edema

  MAUDE report 20482047 ↗
• MalfunctionSep 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT CAME TO THE ER WITH PAIN AND LEAKING AT INSERTION SITE OF PICC. THE PICC WAS PULLED AND THERE WAS A HOLE AT 5 CM MARK. ADDITIONAL INFORMATION: PATIENT CAME TO EMERGENCY DEPARTMENT ON (B)(6) 2024 WITH COMPLAINTS OF PAIN WITH FLUSHING AND NOTED INTERMITTENT LEAKAGE OF MEDICATION OUT HER INSERTION SITE. PATIENT HAD A WORK-UP WHICH INCLUDED A CHEST X-AY VERIFICATION OF PICC TIP PLACEMENT IN DISTAL SVC. PATIENT WAS SENT HOME. PATIENT RETURNED TO EMERGENCY DEPARTMENT ON (B)(6) 2024 AFTER BEING SEEN BY HER HOME HEALTH STAFF WHO RECOMMENDED SHE BE SEEN IN ED AGAIN. I SAW THE PATIENT IN THE ED, RECOMMENDED A VENOUS DUPLEX (WHICH WAS NEGATIVE) AND ASSESSED THE PICC LINE. WITH POSITIONING CHANGES, PATIENT WOULD HAVE INTERMITTENT ABILITY TO EASILY FLUSH AND BRISK BLOOD RETURN AND AT OTHER TIMES, IT WOULD CEASE. AT THIS TIME, WE DID NOT OBSERVE SALINE SOLUTION LEAKING FROM INSERTION SITE BUT PATIENT DID HAVE LEAKAGE NOTED UNDER HER DRESSING AND A SATURATED CHG IMPREGNATED DISK. I THOUGHT IT COULD BE POTENTIALLY PINCH OFF SYNDROME. WE CHANGED THE DRESSING AND RE-FLUSHED WHICH IMMEDIATELY CAUSED PAIN TO PATIENT'S UPPER ARM, LATERALLY TO PICC INSERTION SITE AND COPIOUS

  Patient problems: Pain

  MAUDE report 20193123 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, HAVING TO REMOVE A PICC LINE DUE TO THE PATIENT COMPLAINING OF PAIN. WHEN THEY REMOVED THE PICC, THEY NOTICED A TEAR IN THE PICC AT THE 5CM LINE. PICC HAD TO BE REMOVED, AND A NEW ONE WAS PLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 19921888 ↗
• MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PICC WAS PLACED BY RN ON (B)(6) 2024. NO ISSUES REPORTED ABOUT INSERTION/PLACEMENT. WAS DISCHARGED HOME AFTER PICC PLACEMENTS TO RECEIVE HOME ABX. HOME HEALTH WAS MANAGING THE INFUSIONS AND CARE AND MAINTENANCE. NO REPORTED ISSUES. PATIENT WAS RE-ADMITTED ON (B)(6) 2024, PICC WAS STILL IN PLACE AND WAS BEING USED DURING HOSPITAL STAY. NO REPORTED ISSUES DURING THIS TIME. PATIENT CAME IN ON (B)(6) 2024 TO GET A DRESSING CHANGE. STAFF REPORTED BLEEDING AT THE INSERTION SITE. WHEN VAT TEAM WENT TO ASSESS THE SITE, STATED THE PICC DREW BLOOD BUT WHEN SHE WENT TO FLUSH, SALINE WAS COMING OUT OF THE INSERTION POINT. PICC WAS REMOVED AND A HOLE AT THE 5CM MARK WAS NOTED. PICC WAS CHARTED AT 0CM. NO ADVERSE EVENT TO CLINICIAN OR PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805161 ↗
• MalfunctionJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, "OUR PATIENT HAD HER PICC LINE PLACED MAY 20TH, SHE CAME TO THE ED YESTERDAY BECAUSE SHE SAID SHE FELT A POP WHEN GIVING MEDS ON PRIOR EVENING. LONG STORY SHORT, I REMOVED IT (IT WAS PLACED TO THE 0CM MARK) AND BETWEEN THE 6 AND 7CM MARK THERE IS A HOLE/SLIT." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 06/12/2024: "PATIENT ADMITTED TO ED WITH COMPLAINTS OF PAIN AROUND THE PICC SITE. PATIENT STATES THAT SHE FELT A POP YESTERDAY EVENING WHEN SHE WAS FLUSHING HER PICC AND IT SCARED HER. UPON VISUAL ASSESSMENT, SITE APPEARS WITHIN NORMAL LIMITS OTHER THAN SOME VARIOUS REDDENED AREAS THAT APPEAR TO BE MEDICAL ADHESIVE INJURY. UPON PALPATION OF SITE, THERE IS A SLIGHTLY FIRM PALPABLE EDEMATOUS AREA APPROX 4CM ABOVE INSERTION SITE TOWARDS AXILLA AREA, NOT PAINFUL WITH PALPATION. AT 1651, OLD DRESSING REMOVED. SITE CLEANSED PER P&P AND STERILE DRESSING CHANGE COMPLETED WITHOUT COMPLICATIONS. AFTER COMPLETING THE DRESSING CHANGE, PRN END CAP CHANGED AND PICC CATHETER FLUSHED. PATIENT INSTANTLY STATED HAVING PAIN JUST ABOVE INSERTION SITE (PREVIOUSLY NOTED EDEMATOUS AREA) AND THE SALINE FLUSH DID NOT FEEL NORMAL TO THE RN. THE RN THEN USED ULTRAS

  Patient problems: Erythema; Infiltration into Tissue; Swelling/ Edema

  MAUDE report 19639833 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, INSERTED A PICC LINE ON (B)(6). EVERYTHING WENT WELL. BEGAN LEAKING A SMALL AMOUNT DURING DAILY INFUSION ONE WEEK AGO WITH DIFFICULTY FLUSHING UNLESS ARM WAS DOWN BY HER SIDE. SHE CAME IN BECAUSE ALL MEDICATION WAS LEAKING FROM UNDER THE DRESSING WHEN SHE DID HER INFUSION. WHEN THEY FLUSHED IT, SALINE SHOT OUT OF THE INSERTION SITE. THE CATHETER WAS ONLY 1 CM OUT. THEY DID A PICC EXCHANGE AND FOUND THE CATHETER WAS SLIGHTLY BENT AND FRACTURED JUST BEFORE THE 5CM MARK. IT WORKED FOR A MONTH. PICC IS SPLIT ON OPPOSITE SIDE ON WHERE IT WAS BENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549670 ↗
• InjuryJun 5, 2024Break; Break

  IT WAS REPORTED A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACED ON RIGHT BASILIC VEIN. THE LINE SITE LOOKED INFLAMED/IRRITATED AND ANTIBIOTICS BEING ADMINISTERED THROUGH IT WERE LEAKING. ORDER TO REMOVE THE PICC WAS OBTAINED. THE REGISTERED NURSE (RN) NOTED UPON REMOVAL THE LINE WAS NOT INTACT, APPROXIMATELY 8" WERE RETRIEVED. THE END OF THE PORTION RETRIEVED LOOKED FRAYED. A CHEST X-RAY (CXR) WAS TAKEN AND THE REST OF THE PICC LINE WAS FOUND IN THE MAIN AND RIGHT PULMONARY ARTERIES. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE RETAINED PORTION WAS REMOVED. THE RETAINED FRAGMENT MEASURES APPROXIMATELY 14". PATIENT HAD NO COMPLICATIONS FROM THE RETENTION OR REMOVAL OF THE RETAINED FRAGMENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19470934 ↗
• MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY NOTED LEAKING AT THE INSERTION SITE. THERE WAS A PICC LUMEN THAT A HORIZONAL SPLIT AT THE 7CM MARK. PICC PLACED ON (B)(6) 2024 BY PICC RN. RN STATED NO ISSUES WITH PLACEMENT. PATIENT WAS DISCHARGED HOME ON (B)(6) 2024 WITH THE PICC LINE. PICC LINE WAS WORKING AT TIME OF DISCHARGE. PATIENT CAME BACK INTO THE ED ON (B)(6) 2024 DUE TO HIS HOME HEALTH NURSE BEING UNABLE TO OBTAIN BLOOD RETURN FROM THE PICC LUMEN AND REPORTED DIFFICULTY FLUSHING THE LINE. THE ED CONFIRMED IN THE CHART THAT UPON ARRIVAL THE PICC LUMEN WAS NOT WORKING PROPERLY. CATHFLO WAS GIVEN IN THE ED AND THE NURSE REPORTED THAT THE LINE FLUSHED AND DREW BLOOD. PATIENT WAS DISCHARGED HOME. PATIENT ARRIVED TO THE ED ON (B)(6) 2024 DUE TO THE PICC LINE LEAKING. PATIENT REPORTED THAT HE HAS BEEN GETTING DAILY ABX WITH NO PAIN OR DIFFICULTY FLUSHING THE LINE. HOWEVER, PATIENT REPORTED THAT THE HOME HEALTH NURSES WERE STATING "BLOOD RETURN DIFFICULTIES". THE VASCULAR ACCESS TEAM WAS CONSULTED TO THE ED. WHEN RN ARRIVED, THEY NOTICED NO LEAKING AT THE SITE WHEN FLUSHED. AFTER RE-DRESSING THE LINE THEY NOTED LEAKING AT THE INSERTION SITE AND ALSO NOTED SWELLING AROUND THE INSERTION SITE

  Patient problems: Swelling/ Edema

  MAUDE report 19281026 ↗
• InjuryApr 2, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT ATTEMPT WAS MADE TO PLACE 3CG SHERLOCK PICC LINE IN RIGHT BASILIC VESSEL. VESSEL WAS ACCESSED WITH BLOOD RETURN. MICROPUNCTURE WIRE INSERTED THROUGH ACCESS NEEDLE. RESISTANCE WAS MET AND I IMMEDIATELY STOPPED ADVANCING THE WIRE. TRIED TO REMOVE THE WIRE AND MET RESISTANCE SO STOPPED AND TRIED TO REMOVE THE WIRE AND NEEDLE TOGETHER AND STILL COULD NOT REMOVE WIRE. NEEDLE WAS REMOVED WITH WIRE LEFT IN PLACE. IR CALLED TO ASSESS PATIENT. FLUOROSCOPY WAS USED AND WIRE WAS SHOWN TO HAVE LOOPED AND THERE WAS A KNOT AT END. IT WAS RECOMMENDED TO PUT DILATOR OVER WIRE TO TRY TO STRAIGHTEN OUT WIRE. THE WIRE DID START COMING OUT AND WAS PULLED OUT BY DOCTOR TOGETHER WITH THE DILATOR. THE WIRE WAS SHREDDED AND FLUORO WAS TAKEN AND A SMALL PIECE OF THE WIRE WAS RETAINED IN THE ARM. DOCTORS DISCUSSED AND AGREED WIRE WAS NOT IN VESSEL AND WILL REVIEW FURTHER. ADDITIONAL INFORMATION PROVIDED 03/21/2024: IT WAS REPORTED, "NO SERIOUS HARM. A FRAGMENT OF THE WIRE WAS LEFT IN THE PATIENT, BUT WAS FIXED AND DID NOT NEED REMOVED."

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028708 ↗
• MalfunctionOct 11, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT LEAKING AT THE T CONNECTOR ON A PICC LINE THEY USED YESTERDAY. LEAKING FROM STOPPER NOTED WHILE THE PICC WAS BEING FLUSHED DURING THE INSERTION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913388 ↗
• MalfunctionAug 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT RUBBER STOPPER IS LEAKING. IT ALSO CAN SUCK AIR IN WHEN DRAWING BACK BLOOD. ADD INFO RECEIVED ON 07-AUG-2023 (2ND CUSTOMER RESPONSE) CATHETER LEAK DISCOVERED DURING A PREVIOUS PICC INSERTION, WHICH HAS ONLY BEEN SINCE THE CHANGE OCCURRED IN THE PICC INSERTION KITS WITH THE RUBBER STOPPER. NO INTERRUPTION OF TREATMENT. OR LIFE THREATENING SITUATION. NORMAL SALINE USED FOR FLUSHING AND DRAWING BACK TO CHECK PATENCY/BLOOD RETURN. PLEASE NOTE THAT THE POTENTIAL TO ASPIRATE AIR INTO CATHETER EXISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596918 ↗
• MalfunctionAug 14, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "CUSTOMER REPORTED A HAIR FOUND IN A 4 FR PICC LINE KIT. THERE WAS NO PATIENT HARM." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540834 ↗
• MalfunctionJun 8, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER THAT THERE IS LEAKAGE FROM T-LOCK CONNECTION OF PICC WHEN FLUSHING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088935 ↗
• MalfunctionSep 13, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED "PICC KIT WAS SHIPPED WITH HAIR INSIDE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414740 ↗
• MalfunctionNov 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED A 4FR SL PICC KINKED JUST WITHIN THE INSERTION SITE. ADD INFO RCVD (B)(6) 2022: KINKED AT 7.5 CM DISCOVERED VIA XRAY WHEN UNABLE TO FLUSH OR ASPIRATE PICC WAS THERE PATIENT HARM REPORTED?: SOME DISCOMFORT IN ARM PLACEMENT DATE (B)(6) 2021. PLACEMENT INFO: PLACED IN PT ON 5G 17 (RENAL UNIT). WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: BARD STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836350 ↗
• MalfunctionJun 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED "SINGLE LUMEN PICC PLACED ON (B)(6) 2021. CXR OBTAINED AND CONFIRMED PROPER PLACEMENT. A FEW HOURS LATER, IT WOULD NOT FLUSH. ON (B)(6) AN EXCHANGE WAS DONE AND A KINK WAS OBSERVED AT ABOUT THE 10CM MARK." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093377 ↗
• MalfunctionMar 5, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "BREAKAGE." ADD INFO RCVD (B)(6) 2021: IT WAS NEVER INSERTED INTO THE PATIENT. INCIDENT OF BREAKAGE OCCURRED DURING PREPPING THE PICC WHEN ADJUSTING THE LENGTH OF STYLET AFTER TRIMMING OF CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11422696 ↗
• InjuryNov 20, 2020Break; Material Frayed; Failure to Advance; Material Frayed

  IT WAS REPORTED THE SHERLOCK WIRE BROKE OFF IN THE PATIENT WHEN REMOVING FROM PICC. ADDITIONAL INFORMATION RECEIVED 11/03/2020: PER PROGRESS NOTES BY VAT RN: ¿VAT CONSULTED FOR PICC PLACEMENT. CAN ONLY USE RIGHT ARM DUE TO PATIENT'S LEFT ARM FLACCID. RIGHT BASILIC VEIN ACCESSED AND NEEDLED VISUALIZED IN THE VEIN. INTRODUCER INSERTED. BLOOD RETURN PRESENT. WHEN ATTEMPTING TO INSERT PICC, PICC MET RESISTANCE. UNABLE TO ADVANCE PICC MORE THAN 28CM. ABORTED PROCEDURE. WHEN REMOVING PICC WITH ECG/GUIDE WIRE, NOTICED THE WIRE TIP WAS NOT INTACT. REMOVED INTRODUCER AND HELD PRESSURE FOR 10 MIN. HEMOSTASIS ACHIEVED. GUAZE AND TEGADERM APPLIED. PATIENT MADE AWARE OF UNABLE TO INSERT PICC. PRIMARY RN UPDATED. CALLED DR. AND NOTIFIED HER. CHEST XRAY ORDERED.¿

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 10876428 ↗
• MalfunctionJul 23, 2019Unsealed Device Packaging

  IT WAS REPORTED THE RN WENT TO GET THE KIT OFF THE SHELF AND WHEN SHE PICKED IT UP, NOTICED THE SEAL WAS NOT INTACT. THE RN DID NOT UTILIZE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8818894 ↗
• MalfunctionMay 15, 2019Unsealed Device Packaging

  IT WAS REPORTED THAT THE OUTER PACKAGING ON THE KIT WAS NOT COMPLETELY SEALED. THE DEVICE WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8612716 ↗