PowerPICC SOLO2 Catheter with Sherlock Tip Location System (TLS) Stylet 9295108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741035760), received between Feb 26, 2016 and Jun 16, 2025 — classified as 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED ON (B)(6), I HAD A SAFETY NEEDLE FAILURE. I WAS MOVING THE GREEN SAFETY BARREL TO THE END OF THE NEEDLE AND IT DIDN'T STOP, IT JUST CAME ALL THE WAY OFF THE END. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216363 ↗
• MalfunctionJun 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED I WAS MOVING THE GREEN SAFETY BARREL TO THE END OF THE NEEDLE AND IT DIDN'T STOP, IT JUST CAME ALL THE WAY OFF THE END. CUSTOMER HAS HAD THE SAME ISSUE HAPPEN NOW MULTIPLE TIMES. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF OCCURRENCES WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216359 ↗
• InjuryApr 29, 2025Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER PICC INSERTED (B)(6) 2025 BUT FOUND RETAINED FOREIGN BODY (TLS GUIDEWIRE TIP) FRACTURED ON (B)(6) 2025 VIA X-RAY, CONFIRMED VIA CT WITH CONTRAST ON (B)(6) 2025 AND HAD TO BE RETRIED ON (B)(6) 2025. 2 PICCS HAD TO BE USED FOR ORIGINAL PLACEMENT, 1ST PICC PLACED ON THE RIGHT BUT DIFFICULTY BEYOND AXELLA SO THAT ONE WAS ABORTED AND A 2ND PICC WAS ATTEMPTED AND SUCCESSFULLY PLACED ON THE LEFT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21929147 ↗
• MalfunctionJan 23, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, "ON DECEMBER 24, I HAD A SAFETY NEEDLE FAILURE. I WAS MOVING THE GREEN SAFETY BARREL TO THE END OF THE NEEDLE AND IT DIDN¿T STOP, IT JUST CAME ALL THE WAY OFF THE END."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219485 ↗
• InjuryMar 8, 2023Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH THAT THEY WERE UNABLE TO PASS THE PICC THROUGH THE BRACHIAL PAST 11CM. IT WAS DIFFICULT TO REMOVE THE LINE AS THOUGH THE VESSEL AS VASO SPASMED. AFTER WAITING APPROXIMATELY 10 SECONDS, THE PATIENT WAS REPOSITIONED, AND CLINICIAN ATTEMPTED TO PASS 11 CM UNSUCCESSFULLY. BASILIC AND CEPHALIC VEINS ARE TOO SMALL FOR THE PICC ON THE RIGHT ARM SO THE CLINICIAN MOVED TO THE LEFT SIDE. STERILE FIELD AS MAINTAINED, AND CLINICIAN FOUND APPROPRIATELY SIZED BASILIC VEIN AND CONTINUED THE PROCEDURE. CATHETER PASSED EASILY. CATHETER DRESSED PER HOSPITAL PROTOCOL. CUSTOMER REPORTS A SMALL WIRE FRAGMENT WAS PRESENT MEDIAL TO THE PROXIMAL SHAFT OF THE RIGHT HUMERUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16501687 ↗
• InjuryApr 26, 2021Break; Break

  IT WAS REPORTED THAT RIGHT UPPER EXTREMITY PICC LINE PLACED FOR LONG TERM USE. PLACEMENT TRANSPIRED WITHOUT ISSUE. FOREIGN BODY WAS LATER OBSERVED ON IMAGING SHOWING AN APPROXIMATELY 2.5CM CURVE LINEAR HIGH DENSITY FOREIGN BODY IN THE SUB SEGMENTAL BRANCH OF POSTERIOR BASAL SEGMENT OF RIGHT LOWER LOBE WHICH IS LIKELY TO BE A FRAGMENT OF PREVIOUSLY PLACED PICC. RETRIEVAL POSTPONED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11724018 ↗
• MalfunctionApr 15, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "RN WAS INSERTING A PICC LINE IN RIGHT BASILIC VEIN. SHE ACCESSED THE VEIN WITH 21G NEEDLE. SHE GOT STEADY BLOOD FLOOD DRIPPING OUT. SHE INSERTED THE INTRODUCER FLEXURA WIRE BUT IT WOULD NOT ADVANCE SMOOTHLY. SHE COULDN¿T RECALL HOW MUCH SHE GOT IN, BUT IT WAS MORE THAN THE NEEDLE LENGTH. SHE STARTED TO RETRACT THE WIRE, BUT MET RESISTANCE SO SHE RETRACED NEEDLE AND WIRE TOGETHER BUT ONLY THE NEEDLE WOULD RETRACT. SHE NOTICED THAT THAT DISTAL TO THE NEEDLE TIP THE WIRE WAS NO LONGER INTACT. IT WAS UNRAVELING BUT STILL CONNECTED. SHE STOPPED AND HAD A PHYSICIAN COME IN. HE MADE A TINY INCISION AND THEY WERE ABLE TO REMOVE THE WHOLE WIRE. A PICC WAS PLACED ON THE LEFT ARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675553 ↗
• InjuryMar 1, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "HOSPITAL HAS A BROKEN WIRE TIP TODAY." ADDITIONAL INFO. RECEIVED 02/04/2021 "PICC WAS PLACED ON LEFT SIDE USING ULTRASOUND MODIFIED SELDINGER METHOD USE. THE VEIN WAS CANNULATED WITHOUT ISSUE, THE WIRE WAS THREADED THRU NEEDLE, NEEDLE REMOVED, INTRODUCER THREADED OVERWIRE. WIRE REMOVED ATTEMPT TO THREAD PICC. IT WOULD ONLY GO A LITTLE PAST SHOULDER. AFTER REPOSITIONING PT AND SEVERAL ATTEMPT TO PLACE, A NITINOL WIRE WAS USE IN THE PURPLE LUMEN IT WAS ABLE TO MOVE DOWN TO SVC. NITONOL WIRE REMOVED INTACT. SHERLOCK WIRE REMOVED. FROM RED PORT. BOTH PORTS FLUSHED EASILY WITH GOOD BLOOD RETURN. THE SHERLOCK WIRE WAS NOTED TO BE CURLED UP BUT SEEMED TO BE INTACT. XRAY TAKEN: THE PICC TERMINATED IN THE HEMIZYGOUS VEIN PROBABLY DUE TO STENOUS OF THE BRACHIOCEPHALIC VEIN . FOREIGN BODY WAS NOTED IN BRACHIOCEPHALIC VEIN. PT WAS TAKEN TO CT CONFIRMED WIRE FRAGMENT . PT WAS TAKEN TO CATH LAB AND THE WIRE WAS RETRIEVED BY THE IR MD. PICC WAS PULLED." IT WAS REPORTED VIA MEDWATCH "TIP OF GUIDEWIRE PROTRUDED FROM 5 FR POWER PICC RESULTING IN 37MM OF THE TIP OF SHERLOCK WIRE TO BREAK OFF FROM WIRE CAUSING A RETAINED FOREIGN OBJECT X-RAY IMAGES USED USED TO VERIFY PLACEMENT AND RE

  Patient problems: Foreign Body In Patient

  MAUDE report 11395948 ↗
• MalfunctionNov 13, 2020Fluid/Blood Leak

  IT WAS REPORTED " THE [PICC] WAS INSERTED INTO PATIENT AND IT LEAKED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837658 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "PICC EXTRAVASATION". ADDITIONAL INFORMATION RECEIVED(B)(6)2020 : "ON(B)(6)2020 , THE PATIENT UNDERWENT A CTA OF THE CHEST. APPROXIMATELY 50 MLS OF THE CONTRAST, WHICH WAS BEING DELIVERED VIA THE PICC LINE, EXTRAVASATED WITHIN THE MEDIASTINUM AND INTO THE RIGHT PLEURAL SPACE SUGGESTING A DEFECT OR PERFORATION OF THE SUPERIOR VENA CAVA. AT THE PRESENT TIME THE MAIN CONCERN IN THIS PATIENT IS THE FACT THAT SHE HAS EXTRAVASATION OF DYE INTO THE MEDIASTINUM WHICH IS CONCERNING FOR AN SVC PERFORATION SECONDARY TO THE PICC LINE. DR. HAS REQUESTED A CT OF THE CHEST TO BE OBTAINED STAT TO RULE OUT ANY DEVELOPMENT OF ANY HEMATOMA. AS LONG AS PATIENT IS HEMODYNAMICALLY STABLE AND NO EVIDENCE OF ANY HEMATOMA OR ANY WORSENING LEAKAGE DR. WILL BE PLANNING ON POSSIBLY REMOVING THE PICC LINE TOMORROW MORNING UNDER CONTROLLED CIRCUMSTANCES IN THE CATH LAB. IN THE MEANTIME, THE PICC LINE IS TO REMAIN IN PLACE AND NOT BE USED. WE WILL TRY TO PLACE PERIPHERAL IV ACCESS TODAY. PATIENT WILL BE TRANSFERRED TO THE INTENSIVE CARE UNIT. THE DUONEB WILL BE DISCONTINUED AND WILL START HER ON ATROVENT. I WILL DISCONTINUE THE AMIODARONE AND PUT HER ON AMIODARONE DRIP WITH A BOLUS AGAIN. AN ECHO

  Patient problems: Arrhythmia; Great Vessel Perforation; Pleural Effusion

  MAUDE report 9879206 ↗
• InjuryMar 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "INSERTION WIRE NOTED ON IMAGING. VENDOR SAFETY STRATEGIES TO PREVENT INADVERTENT SHEARING DURING INSERTION. CONSIDER COLORING THE TIP OF THE GUIDEWIRE AND THE STYLET A DIFFERENT COLOR EACH (NOT RED) THIS WILL ASSIST THE PRODECURALIST IN DETERMINING IF THE ENTIRE WIRE HAS BEEN WITHDRAWN).¿

  Patient problems: Foreign Body In Patient

  MAUDE report 9826242 ↗
• InjuryMay 10, 2019Entrapment of Device

  AN 8MM OF GUIDEWIRE NOTED TO BE IN CATHETER AFTER PLACEMENT WAS VERIFIED BY CHEST XRAY. PICC LINE REMOVED AND REPLACED WITH A MIDLINE. REMOVED PICC LINE WAS XRAY AND THE SECTION OF GUIDEWIRES STILL IN CATHETER. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Information

  MAUDE report 8604252 ↗
• MalfunctionFeb 15, 2019Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE PICC LINE NURSES WAS PLACING A PICC IN A PATIENT ON MONDAY (B)(6) 2019. THE PATIENT HAS A HISTORY OF MULTIPLE CENTRAL LINE PLACEMENTS. IT WAS STATED THAT WHEN THE PICC NURSE WAS MAKING AN ATTEMPT ON THE RIGHT ARM WITH THE LINE WHEN IT ¿KINKED¿ AT SOME BLOCKAGE. SHE PULLED THE LINE OUT AND INSPECTED THE WIRE TIP, WHEN SHE TOUCHED THE TIP IT FELL OFF IN HER HAND. IT WAS SAID THAT IT "APPEARS TO HAVE BROKEN OFF AT THE KINK INSIDE OF THE CATHETER". ON (B)(4) 2019- ADDITIONAL INFORMATION RECEIVED STATED A NEW DEVICE WAS PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346234 ↗
• MalfunctionNov 1, 2018Leak/Splash

  IT WAS REPORTED THAT AFTER WHAT APPEARED TO BE A SUCCESSFUL INSERTION, THE PICC WAS FLUSHED AND ASPIRATED, WHEN THEY NOTICED A LOT OF AIR BUBBLES IN THE SYRINGE (LIKELY INDICATING AN AIR LEAK OR HOLE SOMEWHERE IN THE LINE). THEY OPENED A NEW KIT, REPLACED THE CATHETER AND IT WAS STATED EVERYTHING FUNCTIONED NORMALLY WITH THE SECOND DEVICE.

  Patient problems: No Information

  MAUDE report 8028461 ↗
• MalfunctionNov 17, 2017Break; Kinked

  FACILITY REPORTED THAT PICC NURSE INSERTED PICC SUCCESSFULLY AND WHEN SHE BEGAN TO RETRACT THE GUIDEWIRE SHE FELT A LOT OF TENSION AND THE GUIDEWIRE SNAPPED AND CAME OUT KINKED. NO PART OF THE PICC OR GUIDEWIRE WAS LEFT INSIDE OF THE PATIENT. THE PATIENT WAS NOT HURT. THE PICC NURSE OPENED ANOTHER KIT AND A NEW DEVICE WAS PLACED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043061 ↗
• MalfunctionAug 16, 2017Unraveled Material

  IT WAS REPORTED BY THE FACILITY THAT THE NURSE HAD AN ISSUE WITH THE MICROEZ INTRODUCER NEEDLE IN THE PATIENT, WHEN RETRACTING THE NEEDLE, THE GUIDEWIRE UNRAVELED AND SHE ALMOST LOST THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6799249 ↗
• MalfunctionJul 7, 2017Break; Unsealed Device Packaging

  IT WAS REPORTED BY THE FACILITY, VIA THE SALES REP, THAT ONE OF THE PROCEDURE NURSES WENT TO USE A PRODUCT ON (B)(6) 2017 AND THE PACKAGING SEAL WAS BROKEN, SO SHE COULD NOT USE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692367 ↗
• MalfunctionMay 13, 2016Material Fragmentation

  DISCOVERED A RETAIN FOREIGN BODY IN LEFT CHEST DURING A CARDIAC CATH (B)(6) 2016 ON A PT THAT WAS NOT PRESENT PRIOR TO A PICC LINE PLACEMENT. A SMALL FRAGMENT OF ONE OF THE GUIDE WIRES APPEARS TO BE THE FOREIGN BODY. ONE GUIDE WIRE WAS FOUND TO BE INTACT. THE COPPER WIRE WAS DISPOSED OF AND NOT ABLE TO DO A VISUAL EXAMINATION OF IT. THE PICC CATHETER WAS INTACT AND USABLE WITH NO PROBLEMS TO THE PT. PT WAS TOO ILL TO HAVE THE WIRE REMOVED. MD OPINION THAT ANY ATTEMPTS TO REMOVE WOULD RESULTS IN MAJOR PROBLEMS FOR THE PT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5662250 ↗
• InjuryMay 4, 2016Use of Device Problem

  ON (B)(6) 2016 - PER MEDWATCH FORM, "RETAINED PIECE OF CATHETER. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: PICC LINE FOR CHEMOTHERAPY." ON (B)(6) 2016 - NURSE FROM FACILITY REPORTED THAT THEIR TEAM INVESTIGATED THIS CASE AND FOUND THAT THERE WERE NO ISSUES IN THE PRODUCT (PICC LINE). NURSE STATED IT WAS AN OPERATOR ERROR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5632686 ↗
• MalfunctionApr 8, 2016Break

  ON (B)(4) 2016 - IT WAS REPORTED BY THE COMPLAINANT, "ATTEMPTED PLACEMENT OF PICC IN THE PATIENT'S CEPHALIC VEIN. SHERLOCK APPEARED TO SHOW PICC TURNING BACK ON ITSELF IN THE AXILLA. HEALTH PROFESSIONAL ADVANCED A SECOND WIRE DOWN THE OTHER LUMEN TO RESOLVE THE MALPOSITION. THE PICC STRAIGHTENED OUT. WHEN ATTEMPTING TO WITHDRAW THE SHERLOCK STYLET (THE SHERLOCK ICON ON THE SCREEN DID NOT MOVE). MAGNET TIP WAS MISSING FROM THE STYLET, WITHDREW THE PICC AND FOUND THE MAGNET TIP STILL IN THE PICC. DOCTOR COMPARED THE STYLET IN QUESTION TO ANOTHER STYLET FROM THE SAME LOT AND DETERMINED THAT THEY HAD RETRIEVED THE ENTIRE STYLET, NO HARM TO THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5564443 ↗
• InjuryApr 8, 2016Sticking

  ON (B)(6) 2016 - IT WAS REPORTED BY COMPLAINANT, THAT THE STYLET WAS STUCK IN THE PICC DURING PLACEMENT AND THE PATIENT HAD TO BE REFERRED TO ANOTHER FACILITY FOR PICC REMOVAL. THE PATIENT WAS NOT HARMED. THE OTHER FACILITY DID NOT RETAIN OR WILL NOT RELEASE THE REMOVED PICC/STYLET. ON (B)(6) 2016 - AS REPORTED BY COMPLAINANT, THEY WERE ABLE TO OBTAIN THE STYLET AND HAVE A CD OF THE X-RAY. ON (B)(6) 2016 - AS REPORTED, THE OTHER FACILITY THAT THE PATIENT WAS SENT TO HAVE THE PICC REMOVED WAS IR.

  Patient problems: No Information

  MAUDE report 5564439 ↗
• InjuryFeb 26, 2016Entrapment of Device

  FACILITY CONTACT REPORTED THAT A PATIENT HAD A PICC PLACED IN (B)(6) 2013 FOR THREE DAYS. THE PICC WAS REMOVED ONCE TREATMENT HAD CONCLUDED AND THE PATIENT WAS SENT HOME OK. IN (B)(6) 2016, THE PATIENT CAME TO THE SAME HOSPITAL WITH SHORTNESS OF BREATH. A CT WAS DONE WHICH SHOWED 3-4 CM OF A METALLIC OBJECT EMBEDDED IN THE PULMONARY ARTERY. NURSE WAS UNSURE IF THIS OBJECT WAS FROM THE PICC LINE FROM THREE YEARS AGO OR FROM A PREVIOUS CVC CATHETER IMPLANTED AND REMOVED BEFORE THE PICC. CONTACT STATED THAT THERE ARE NO PLANS TO REMOVE THE OBJECT AT THIS TIME AS IT WOULD REQUIRE OPEN HEART SURGERY.

  Patient problems: Dyspnea; Foreign Body In Patient

  MAUDE report 5464796 ↗