PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9194118Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741028618), received between Nov 17, 2015 and Mar 18, 2025 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THE PICC CATHETER BROKE BETWEEN 6-7 CM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21635420 ↗
• MalfunctionNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY CUSTOMER THAT PT HAD THIS PICC INSERTED (B)(6) ,2020. ON (B)(6) ,2023 IT WAS NOTED THAT THIS PICC WAS MAL POSITIONED. NEW PICC PLACED WITH NO ISSUES. PICC REMOVED BY UNIT RN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18154943 ↗
• InjuryOct 19, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE POWERPICC SOLO BROKE AT APPROX. THE 15CM MARK WHEN HCP ATTEMPTED TO REMOVE. PATIENT HAD PICC INSERTED IN 2020 IN THE LEFT BASILIC VEIN FOR CHEMOTHERAPY TREATMENTS, UNSURE OF ANY OTHER MEDICATIONS THAT WERE INFUSED. THE CUSTOMER STATED THE X-RAY SHOWED THE PICC IS FRACTURED IN 2 PLACES, FIRST BREAK AT THE AXILLIA. THE BROKEN SECTIONS REMAIN IN THE BRACHIOCEPHALIC VEIN. FURTHER INVESTIGATION IS REQUIRED BY RADIOLOGY TO ASSESS IF THE PIECES CAN BE REMOVED. PICC IN-SITU FOR APPROX. 4 YEARS, BROKEN SECTION OF PICC REMAINS IN THE PATIENT, UNCERTAIN OF REMOVAL. ADDITIONAL INFORMATION RECEIVED 17-OCT-2023: IT WAS REPORTED THE EVENT WAS NON-LIFE-THREATENING. THE NURSE ON SHIFT ATTEMPTED TO REMOVE THE CATHETER AND DISCOVERED ONLY 15 CM WAS REMOVED. UPON FURTHER X-RAY, IT WAS NOTED TWO PIECES OF THE CATHETER REMAINED INSIDE THE PATIENT. THERE WERE NO DELAYS IN TREATMENT BUT THE PATIENT WAS VERY UPSET ABOUT THE SITUATION. RADIOLOGY WAS ABLE TO REMOVE THE LARGER PORTION OF THE CATHETER BUT FELT THAT ONE SMALL FRAGMENT REMAINED. IT COULD NOT BE RETRIEVED. CXRS AND FLUOROSCOPY WERE USED TO ASSESS THE INTERNAL PORTION OF THE CATHETER. NO MEDICATIONS WERE IN

  Patient problems: Distress; Foreign Body In Patient

  MAUDE report 17969448 ↗
• MalfunctionAug 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT AFTER CLEAR FLUID NOTED IN DRUG WHEN PICC FLUSHED, APPROXIMATELY 7-8CM THERE IS A SMALL PINHOLE IN THE PICC LINE. THIS WOULD HAVE BEEN APPROXIMATELY 3-4 CM FROM THE INSERTION PIT/FIT UNDER THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597536 ↗
• InjuryJun 23, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "PICC WAS INSERTED USING THE STYLET ON CXR, NOTED FOREIGN BODY AT THE SUBCLAVIAN... 3CM OF STYLET WIRE. PATIENT WILL BE TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR REMOVAL." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049951 ↗
• MalfunctionApr 2, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE NEEDLE WENT INTO THE VEIN FIND AND WHEN THE GUIDEWIRE ADVANCED, THE PATIENT CLAIMED TO FEEL THAT. THE GUIDEWIRE SEEMED TO LOOP AND THE NURSE PULLED BACK ON THE GUIDEWIRE, ENCOUNTERING RESISTANCE WHEN PULLING BACK, BUT FINALLY ABLE TO SLOWLY PULL OUT THE GUIDEWIRE; HOWEVER, IT WAS VERY CLEAR THAT THE WIRE WAS FRAYED, UNRAVELLING, AND BENT AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608847 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2019, NURSE ASSESSED THAT THERE WAS FAIR BLOOD RETURNS AND QUERIED LEAKING SALINE AND SOME BLOOD AT SITE WHEN PT WAS IN FOR PICC CARE AND BLOOD WORK AT ONCOLOGY. PICC NURSE ASSESSED SAME DAY AND FOUND NO LEAK AT THAT TIME. ON (B)(6) 2019 PT RECEIVED CHEMO TX PACLITAXEL AND CARBOPLATIN, AND PICC NURSE WAS NOTIFIED THE FOLLOWING WEEK THAT THE TX ROOM NURSE FOUND LEAKING FROM INSERTION SITE WITH NO BLOOD RETURNS AGAIN. PICC NURSE CONFIRMED LEAKING AT THE SITE. PICC WAS WITHDRAWN 2 CM. FLUSHED AND STILL HAD LEAKING. A PICC EXCHANGE WAS ATTEMPTED AND UNSUCCESSFUL DUE TO LINE CURLING IN THE AXILLA. LINE WAS REMOVED. NEW LINE INSERTION IN NEW SITE ON SAME DATE ((B)(6) 2019). ON REVIEW OF THE ORIGINAL LINE, AN HOLE WAS FOUND AT THE 20 CM MARK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856807 ↗
• MalfunctionFeb 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES WITH LOT NUMBER REDW3820. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770159 ↗
• MalfunctionFeb 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT AT THE FACILITY WHILE INSPECTING THE GUIDEWIRE, THE TIP BROKE OFF EASILY. THE DEVICE WAS NOT USED ON A PATIENT. IT WAS STATED THIS HAPPENED WITH TWO DEVICES WITH LOT NUMBER REDW3820. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770152 ↗
• MalfunctionMar 8, 2019Defective Component

  IT WAS REPORTED THAT POWER PICC CONTINUES TO BLOCK OFF REPEATEDLY. THIS IS APPARENTLY A RECURRING EVENT. THE NUMBER OF OCCURRENCES WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404556 ↗
• InjuryMar 2, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT ON COMPLETION OF PICC INSERTION PATIENT BECAME FLUSHED, HYPOTENSIVE AND TACHYCARDIC. USER SUGGESTS LIKELY MAST CELL ACTIVATION REACTION. PATIENT APPARENTLY REQUIRED SUPPORTIVE MEASURES: 2L CRYSTALLOID, BENADRYL, STEROIDS. IT ALLEGEDLY TOOK CLOSE TO AN HOUR FOR PATIENT TO RECOVER AND CONSIDERATION WAS BEING MADE FOR AN ICU CONSULT.

  Patient problems: Erythema; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 7311521 ↗
• MalfunctionJan 17, 2018Failure to Advance

  IT WAS REPORTED THAT THE PICC WAS INSERTED VIA LEFT ARM BASILICA VEIN, INITIAL DIFFICULTY IN ADVANCING THE CATHETER AS CATHETER WAS GOING TO THE RIGHT IJ, EVENTUALLY WAS ABLE TO DIRECT CATHETER TO DISTAL SVC, FIBRIN NOTED IN CATHETER LUMEN, FIBRIN WAS WITHDRAWN FROM SYRINGE AND SYRINGE FLUSHED WITH NORMAL SALINE, DRESSING COMPLETED. PATIENT SUPPOSEDLY STATED HAVING CHEST PRESSURE, VITAL SIGNS STABLE, NO SHORTNESS OF BREATH. NO APPARENT HARM TO THE PATIENT.

  Patient problems: Chest Tightness/Pressure

  MAUDE report 7201200 ↗
• MalfunctionOct 31, 2017Scratched Material

  IT WAS REPORTED THAT NURSE NOTICED ROUGHNESS OF THE OUTER PORTION OF THE CATHETER ALONG THE CENTIMETER MARKS WHEN RUNNING HER FINGERS ALONG THE EDGE COMPARED TO OTHER CATHETERS. IT WAS STATED THE NURSE FELT AN INCREASE IN "BUMPINESS" RATHER THAN SMOOTHNESS. THE PROCEDURE WAS COMPLETED AND THE CATHETER LEFT IN SITU. THE CATHETER WAS LATER REMOVED. THIS REPORTED ADDRESSES CATHETER THREE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990369 ↗
• MalfunctionOct 31, 2017Material Integrity Problem

  IT WAS REPORTED THAT NURSE NOTICED ROUGHNESS OF THE OUTER PORTION OF THE CATHETER ALONG THE CENTIMETER MARKS WHEN RUNNING HER FINGERS ALONG THE EDGE COMPARED TO OTHER CATHETERS. IT WAS STATED THE NURSE FELT AN INCREASE IN "BUMPINESS" RATHER THAN SMOOTHNESS. THE PROCEDURE WAS COMPLETED AND THE CATHETER LEFT IN SITU. THE CATHETER WAS LATER REMOVED. THIS REPORTED ADDRESSES CATHETER TWO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990367 ↗
• MalfunctionOct 31, 2017Material Deformation

  IT WAS REPORTED THAT NURSE NOTICED ROUGHNESS OF THE OUTER PORTION OF THE CATHETER ALONG THE CENTIMETER MARKS WHEN RUNNING HER FINGERS ALONG THE EDGE COMPARED TO OTHER CATHETERS. IT WAS STATED THE NURSE FELT AN INCREASE IN "BUMPINESS" RATHER THAN SMOOTHNESS. THE PROCEDURE WAS COMPLETED AND THE CATHETER LEFT IN SITU. THE CATHETER WAS LATER REMOVED. THIS REPORTED ADDRESSES CATHETER ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990365 ↗
• MalfunctionMay 23, 2017Kinked; Occlusion Within Device

  IT WAS REPORTED THAT THE PICC LINE WAS FOUND TO BE ALLEGEDLY KINKED IN LEFT ARM AND WAS REMOVED. ORIGINALLY INSERTED TO UPPER SVC, OCCLUSION NOT RESOLVED WITH TPA. CXR SHOWED LINE 10CM SHORTER BUT NO ADDITIONAL LENGTH ON SKIN. OBVIOUS KINK WHEN REMOVED. INFUSED CT PREVIOUS DAY. IT WAS NOTED THAT THIS HAS OCCURRED IN THE PAST NUMEROUS TIMES IN LATE 2015 AND EARLY 2016. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6585332 ↗
• InjuryJan 26, 2016Knotted; Difficult to Remove; Physical Resistance; Difficult to Advance

  IT WAS REPORTED THAT THE CUSTOMER ACCESSED THE RIGHT BASILICA VEIN AND ATTEMPTED TO ADVANCE THE WIRE. THEY WERE ABLE TO ADVANCE IT 15CM THEN APPARENTLY MET RESISTANCE. THEY WERE APPARENTLY UNABLE TO REMOVE THE WIRE. A DERMATOTOMY WAS PERFORMED. THE INTRODUCER WAS INSERTED TO THE POINT OF RESISTANCE AND THEN THEY WERE ABLE TO REMOVE THE WIRE. THEY REPORTED A KNOT IN THE WIRE.

  Patient problems: No Code Available

  MAUDE report 5391700 ↗
• MalfunctionNov 17, 2015Malposition of Device

  IT WAS REPORTED THAT PICC WAS ALLEGEDLY MALPOSITIONED CONTRALATERALLY DURING CT SCAN. - REPORTEDLY, SCOUT SCAN WAS DONE BEFORE CT SCAN AND CONFIRMED THAT PICC TIP WAS IN RIGHT LOCATION (CAVOATRIAL JUNCTION). - POWERPICC WAS USED FOR CT SCAN AND ALLEGEDLY, MALPOSITIONED DURING SCAN. - OVER COURSE OF NEXT 3 DAYS, PICC NURSES REPORTEDLY USED VARIOUS FLUSHING TECHNIQUES TO GET PICC BACK TO PROPER POSITION; ALLEGEDLY, GOT PICC TO GO BACK DOWN SVC. - REPORTEDLY, PICC NURSE CONFIRMED CT WON锠USE THE PICC FOR ANYMORE CT SCANS.

  Patient problems: No Information

  MAUDE report 5231072 ↗