PowerPICC SOLO2 FT Catheter 1295108FDRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00801741034626), received between Dec 15, 2016 and Apr 1, 2026 — classified as 8 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. May 21, 2026Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT PATIENT WAS ENGAGING IN SELF-ACTIVITY WHEN THE PURPLE LUMEN "FELL OFF" THE DUAL LUMEN PICC. THIS CAUSED FOR REMOVAL AND BLOOD LEAKING OUT OF PATIENTS ARM WHERE THE LUMEN HAD "FELL OFF". REMOVED IV ACCESS, PATIENT TRAUMA, HAD TO REPLACE AND GO THROUGH A PICC PROCEDURE AGAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758360 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING PICC LEG. OVERLINE EXCHANGE AFTER AFFECTED LEAKING PICC NOTICED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475683 ↗
• MalfunctionAug 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT THE PICC WAS LEAKING AT THE 0 CM OR 1 CM MARK. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881421 ↗
• MalfunctionJul 28, 2025Material Discolored; Material Discolored

  IT WAS REPORTED THAT THE PICC IS DISCOLORED IN THE AREA WHERE SECUREMENT DEVICE WOULD BE PLACED. NO PATIENT HARM WAS CAUSED AS A RESULT. ON (B)(6) 2025: THE RETURNED DEVICE EXHIBITED DISCOLORATION A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631623 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PICC BROKE AND LEAKED AT THE INSERTION SITE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401554 ↗
• MalfunctionFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S POWER PICC CAME COMPLETELY OUT OF HER ARM. SHE DOES NOT KNOW HOW HER POWER PICC CAME OUT OF HER ARM BUT STATES THE HOME HEALTH NURSE CHANGED THE DRESSING YESTERDAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767050 ↗
• MalfunctionSep 22, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN INSERTION WHERE IT WAS ALLOWING AIR INTO THEIR SYRINGE WHEN THEY ASPIRATED BLOOD DURING INSERTION. THEY TIGHTENED THE CONNECTIONS, AND IT APPEARED TO BE POSSIBLY COMING IN THROUGH THE HUB WHERE THE WIRE IS (THE WIRE THAT WILL BE REMOVED AT THE END OF THE PICC INSERTION). (B)(6) 2023 - AFTER ENGINEER REVIEW CLARIFIED UNDERSTANDING OF THE EVENT, THE EVENT WAS DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798419 ↗
• InjuryApr 18, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED "NOT PICKING UP ECG WAVE FORMS, P WAVE SPECIFICALLY. CANNOT TELL IF IT'S THE SHERLOCK SENSOR OR THE PICC. AN ECHO WAS TAKEN DUE TO PATIENT SYMPTOMS AND SHOWED THE PICC TIP WAS IN THE RIGHT VENTRICLE."

  Patient problems: Unspecified Heart Problem

  MAUDE report 16765636 ↗
• MalfunctionApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE CLINICIAN REPORTED THAT THE MAGNETIC PORTION OF THE SHERLOCK TIP LOCATION SYSTEM WAS FAILING, RESULTING IN A MISREPRESENTATION OF THE CATHETER TIP LOCATION. THE CLINICIAN REPORTED THE 3CG PORTION OF THE SHERLOCK, IN HER OPINION, SEEMS TO BE FUNCTIONING APPROPRIATELY, RESULTING IN A MAXIMALLY HEIGHTEN P WAVE, AS WELL AS A DIAMOND RESPONSE FROM THE SYSTEM. THE CLINICIAN SENT OVER A SCREENSHOT FROM THE SR8. SEE ATTACHMENT. UPON EXAMINATION OF THE EKG STRIP, THE INTRINSIC EKG COMING FROM THE DISTAL PORTION OF THE STYLET APPEARS TO BE HIGHLIGHTED GREEN OVER THE QRS COMPLEX AS OPPOSED TO THE P WAVE. WHEN COMPARED WITH THE EXTERNAL EKG, THE ¿UN-HEIGHTENED¿ P WAVES ON THE INTRINSIC WIRE CORRELATED WITH THE P WAVES ON THE EXTERNAL LEADS. OTHERWISE, MYSELF, AND THE CLINICIAN CAN SEE AND UN-HEIGHTENED P WAVE AND A QRS COMPLEX THAT APPEAR TO BE HIGHLIGHTED GREEN, INDICATING DIAMOND PLACEMENT, FOLLOWED BY A T WAVE. THE DEPTH FINDER WAS GIVEN A RESPONSE OF MID DEPTH. DUE TO THE REPORT, CONCERNS, AND QUESTIONABLE ECG READING, THE CLINICIAN WAS ADVISED TO PERFORM A CHEST X-RAY. THE CHEST X-RAY SHOWED A LEFT-SIDED APPROACHED PICC LINE WITH THE DISTAL TIP AT OR NEAR THE SVC/R ATR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713073 ↗
• MalfunctionJan 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE PICC WAS KNOTTED IN THE AXILLARY CREASE. IT WAS PULLED OUT FINE WITH NO HARM TO THE PATIENT. ONCE CLINICIAN REALIZED IT WAS STUCK IN AXILLARY CREASE, THEY STARTED RUBBING THE SITE BACK AND FORTH. ADD INFO RECEIVED 01/12/2023 CUSTOMER REPORTED THEY PULLED OUT THE WIRE AND DILATOR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16261240 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS AIR BUBBLES. "THIS WEEK WHILE I WAS INSERTING A 5 FRENCH DL PICC LINE, I NOTICED DURING THE PROCEDURE I WAS GETTING AIR INTO MY SYRINGE EVERY TIME I WAS CHECKING FOR A BLOOD RETURN ON THE LUMEN WITH THE WIRE (STYLET WIRE). I REMOVED THE CATHETER FROM THE TRANSDUCER AND FLUSHED THE LINE AGAIN, AND NOTICED THERE WAS AIR BUBBLES COMING FROM THE CLEAR EXTENSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629314 ↗
• MalfunctionApr 22, 2022Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THE INTERNAL ECG WAS NOT WORKING, WHICH INCLUDED DISRUPTION OF THE P-WAVE FORMATION ON THE SCREEN OF THE SITE RITE 8.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189811 ↗
• MalfunctionOct 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAVE DIFFICULT TIME TO INSERT DILATOR, NOT SHARP ENOUGH". ADDITIONAL INFORMATION RECEIVED 10/06/2021: IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "NO ONE INJURED HOWEVER WE ARE NOT ABLE TO INSERT DILATOR SMOOTHLY MOST OF THE TIME, IT KEPT FLOWERING. WE DO NOT WANT TO NICK THE SKIN BECAUSE THE DILATOR IS DULL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706086 ↗
• MalfunctionOct 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "I WAS ASSIST MY NEW MEMBER TO INSERT A PICC LAST FRIDAY , SHE ACCESSED A VEIN WITH 21 G NEEDLE TO BRACHIAL VEIN , VEIN WAS COLLAPSED EVEN WAS RIGHT PLACE, SHE TOOK OUT THE NEEDLE RIGHT AWAY AND NOTICED NEEDLE WAS SPLIT" ADDITIONAL INFO. RECEIVED 10/06/2021 "PATIENT OR INSERTOR WERE NOT INJURED FROM BROKEN 21G NEEDLE. INSERTOR WAS SUCCESSFUL PICC INSERTION WITH 2ND ATTEMPT , USED EXTRA NEEDLE 1 3/4" 20G FROM 1ST OPENED PICC TRAY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705047 ↗
• MalfunctionAug 12, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "AFTER INSERTION AND AFTER PULLING OUT, IT WAS THEN NOTICED THAT THE PICC WIRE HAD BROKE IN HALF. STAFF WAS NOT SURE AT WHICH POINT IT MAY HAVE BROKEN, HOWEVER THERE WAS NO PATIENT HARM. " ADDITIONAL INFORMATION RECEIVED 07/30/2021: IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "IT WAS A TRIPLE PICC, NO PROBLEMS WITH ACCESS. MY CONCERN IS THAT THE CONFIRMATION STYLET CAME APART SPONTANEOUSLY. THERE WAS NO DIFFICULTY WITH ADVANCING THE PICC. WHEN I WENT TO REMOVE THE STYLET TO START CLEANING UP IT WAS THEN THAT I NOTICED THE STYLET WIRE WAS NOT INTACT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315534 ↗
• MalfunctionApr 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED VIA MEDWATCH, SETTING UP PICC PLACEMENT, A LONG PIECE OF HAIR WAS FOUND WITHIN THE PICC KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749782 ↗
• MalfunctionMar 26, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED "ISSUE WITH A SOLO VALVE BREAKING OFF OF THE LINE." ADDITIONAL INFORMATION RECEIVED 03/11/2021 IT WAS REPORTED DOUBLE LUMEN PICC INSERTED. HUB OF ONE OF THE LUMEN CAME OFF DURING PATIENT TURNING. PICC LINE REMOVED DUE TO MALFUNCTION. NEW PICC LINE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577373 ↗
• InjuryFeb 10, 2021Device Dislodged or Dislocated

  IT WAS REPORTED ON JANUARY "14TH, PICC NURSE RECOGNIZED DURING INSERTION WIRE LOST. IR NOTIFIED, WIRE WAS REMOVED VIA IR PROCEDURE FRIDAY JAN 15TH."

  Patient problems: Foreign Body In Patient

  MAUDE report 11310853 ↗
• MalfunctionJan 19, 2021Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED ¿THE OTHER ISSUE IS OUR SHERLOCK TRACKING SYSTEM ISN¿T TRACKING CONSISTENTLY, I AM UNABLE TO TRACK THE CATHETER WITH SHERLOCK AT ALL.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11195263 ↗
• MalfunctionDec 23, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated

  IT WAS REPORTED ¿THE PATIENT ADMITTED TO COUGHING A LOT, WHICH THAT CAN LEAD TO A PICC FLIPPING UP. HOWEVER, TODAY, AFTER PLACING ANOTHER PICC IN LAST WEEK, ALL INDICATIONS WERE THE PICC WAS DOWN HOWEVER, TODAY IT IS FLIPPED UP IN THE NECK.¿ CONFUSED ON THIS ONE. THE CUSTOMER HAS A 5 FR. PROVENA DOUBLE PICC, THAT MIGRATED TO THE NECK AFTER PLACEMENT CONFIRMED WITH 3 CG/SHERLOCK TO MAX P WAVE WITH GREEN DIAMOND." NO COUGHING, NO NAUSEA, SELF AMBULATION, UP AD LIB" ADDITIONAL INFORMATION RECEIVED 11/09/2020: CXR SHOWED PICC UP THE NECK (RIGHT IJ). "PICC FLUSHED AND CXR DICTATED LINE MID-SVC. APPROX. 4CM SHORT OF CAJ."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11065980 ↗
• MalfunctionDec 16, 2020Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A HAIR IN THE 3CG PICC KIT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11023309 ↗
• MalfunctionAug 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED NURSE FOUND A SLASH IS THE DISTAL END TUBING THAT IS USED TO FLUSH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463375 ↗
• MalfunctionAug 13, 2020Material Deformation; Material Deformation

  IT WAS REPORTED A PICC WIRE WAS NOTED TO HAVE A SEVERE KINK IN IT BEFORE IT WAS INSERTED INTO THE PATIENT. THE SCENARIO WAS THAT THE NURSE LOOSENED THE LEUR LOCK AND PULLED THE WIRE BACK PRIOR TO CUTTING THE CATHETER TO IT'S DESIRED LENGTH. WHEN SHE WENT TO ADVANCE THE WIRE BACK THRU THE CATHETER SHE NOTED A SIGNIFICANT KINK IN THE WIRE,ALMOST TO A FRACTURE POINT. THE KINK IS AT APPROXIMATELY 3.5CM FROM THE END OF THE WIRE. THE NURSE DID NOT PLACE THE PICC IN THE PATIENT AS WE HAVE HAD OTHER ISSUES IN THE PAST WITH THE WIRES KINKING AND FRACTURING. THE PICC WASN'T USED ON A PATIENT AND A NEW KIT WAS OPENED FOR PLACEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10405216 ↗
• MalfunctionApr 14, 2020Material Deformation; Material Deformation

  IT WAS REPORTED " LATE LAST WEEK WE HAD YET ANOTHER BENT WIRE IN A PICC KIT. THIS TIME IT WAS NOTICED IT AFTER INSERTION. SHE SAID THE INSERTION WENT VERY SMOOTHLY AND THERE WAS NO RESISTANCE WHEN SHE REMOVED THE WIRE. THE WIRE IS AGAIN BENT IN ALMOST THE EXACT SAME SPOT AS THE OTHER 2 WERE. I HAVE AGAIN SAVED THE WIRE FOR YOU." ON (B)(6) 2020 - RETURNED SAMPLE SHOWS THE WIRE IS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957785 ↗
• MalfunctionDec 4, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSERTION, THERE WAS SOME BLEEDING WHILE THE INTRODUCER WAS IN PLACE DUE TO A HOLE (IN A SPOT WHERE THERE SHOULD NOT BE) IN THE TOP PART OF THE INTRODUCER. PATIENT IS UNHARMED. THE RN THAT PLACED THE DEVICE STATED, "I EVALUATED IT AFTER THE PROCEDURE BY FLUSHING SALINE THROUGH IT, TO SEE WHERE THE INTEGRITY ISSUE WAS. IT APPEARS THAT THERE IS A CRACK, NOT ACTUAL HOLE, WHERE I PUT ARROW FOR YOU TO LOOK. THERE WAS NOT ANY HARM TO THE PATIENT, I JUST PLACED GAUZE UNTIL I COULD TRIM MY PICC AND REMOVE THE INTER-CORE OF THE INTRODUCER THAT WAS LEAKING. THE PART WAS NOT INDWELLING INTO THE PATIENT, AND THE REST OF THE INTEGRITY OF THE INTRODUCER WAS FINE. "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9411156 ↗