PowerPICC SOLO2 HF Catheter with Sherlock Tip Location System (TLS) Stylet 9395108QDRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741035906), received between Jul 7, 2016 and Jul 2, 2024 — classified as 5 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED VIA MEDWATCH AFTER PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE PLACEMENT AND WIRE REMOVED, THE END WAS NOTED TO BE CURLED TIGHT. UNABLE TO VISUALIZE MAGNET AND THE END OF THE LINE. CHEST X-RAY PERFORMED TO CONFIRM PLACEMENT. MAGNET WIRE NOTED TO BE LOCATED IN THE PICC LINE. PICC LINE WAS REMOVED AND CHEST X-RAY WAS TAKEN AGAIN TO CONFIRM THAT LINE HAD BEEN REMOVED. NEW PICC LINE PLACED WITHOUT DIFFICULTY. PICC LINE IS REMOVED, NO OBVIOUS LINEAR RADIOPAQUE DENSITY CAN BE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655231 ↗
• MalfunctionSep 23, 2021Break

  PICC LINE ATTEMPTED TO LEFT SIDE. DIFFICULTY WITH PICC LINE ADVANCING OVER TO THE LEFT SUBCLAVIAN VEIN. MULTIPLE ATTEMPTS MADE TO ADVANCE PICC TO SVC. UPON REMOVING LINE BETWEEN ATTEMPTS, MAGNET NOTICED TO HAVE TIP BROKEN OFF. LINE REMOVED, MAGNET TIP FOUND INSIDE OF LINE AFTER LINE WAS FLUSHED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12525399 ↗
• InjurySep 23, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "GUIDEWIRE OF PICC BROKE OFF IN PATIENT WHILE CLINICIAN WAS TROUBLESHOOTING PICC THAT CROSSED OVER THE CHEST AND DID NOT DROP ON" NO OTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12521368 ↗
• MalfunctionApr 2, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "MAGNET OF PICC STYLET SHEERED IN PATIENT ON INSERTION." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607580 ↗
• InjuryOct 20, 2020Break

  IT WAS REPORTED "WE HAD A MAGNET BREAK OFF A LINE WHILE WE WERE INSERTING IT. CHEST XRAY VERIFIED THAT IT WAS PRESENT IN THE PATIENT¿S LUNG." "WHAT THEY¿RE BEING TREATED FOR: TPN." "OTHER RELEVANT HISTORY: PATIENT WITH HISTORY OF MULTIPLE INFECTIONS REQUIRING IV ANTIBIOTICS AND PICC LINE PLACEMENT." "DOES THE PATIENT HAVE AN INFECTIOUS DISEASE?: HX OF MRSA AND VRE."

  Patient problems: Foreign Body In Patient

  MAUDE report 10707824 ↗
• MalfunctionSep 29, 2020Break; Entrapment of Device

  DIFFICULTY PLACING PICC LINE ON PATIENT. UPON REMOVING WIRE DISCOVERED THE MAGNET WAS BROKEN OFF. CHEST XRAY ORDER AND PHYSICIAN AN MANAGER NOTIFIED. BROKEN PART OF THE WIRE WITH MAGNET WAS FOUND IN THE PATIENT RIGHT LOWER LOBE OF THE LUNG. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10605816 ↗
• MalfunctionFeb 12, 2020Material Frayed; Material Frayed

  IT WAS REPORTED PER MEDWATCH, "PT HAD PICC LINE PLACED. AFTER PLACEMENT IT WAS NOTED THAT A FRAGMENT OF GUIDEWIRE HAD BROKEN OFF."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700617 ↗
• MalfunctionOct 30, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT FACILITY HAD A WIRE BREAK. IT WAS OFF OF A 5 FR TRIPLE LUMEN. NO OTHER INFORMATION PROVIDED AT TIME OF REPORTING. (B)(6) 2019: ADDITIONAL INFORMATION FROM THE FACILITY STATED, "WE DO NOT USE 3CG; IT WAS THE MAGNET WIRE NOT THE GUIDEWIRE. RIGHT ARM BASILIC INSERTION OF TRIPLE LUMEN PICC LINE. DIFFICULTY ENCOUNTERED AROUND SHOULDER. ATTEMPTED SUPINATED ARM AND INSERT. ATTEMPTED TO FLUSH AND INSERT. UPON MOVING RIGHT ARM TOWARD HEAD, LINE MOVED FORWARD AND APPEARED IN THE JUGULAR. ATTEMPTED CHIN TO RIGHT SHOULDER, ATTEMPTED FLUSH. DIFFICULTY VISUALIZING BULLSEYE AT THIS POINT, DID NOT WANT TO REMOVE BEYOND SHOULDER, INSERTED- RECEIVED BLOOD RETURN- FLUSH, BROKE INTRODUCER- REMOVED GUIDEWIRE, REMOVED MAGNET WIRE. UPON INSPECTING TIP OF MAGNET WIRE, NOTED TO BE BROKEN. REMOVE PICC LINE, ASSESSED PATIENT, CHEST XRAY ORDERED. CHEST WAS CLEAR. XRAYED PICC TO NOTE A FRACTURED PIECE OF WIRE INSIDE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9256026 ↗
• InjuryOct 11, 2019Break

  PICC LINE MAGNET BROKEN ON THE TIP OF GUIDEWIRE WHEN REMOVED FROM CATHETER AFTER PLACEMENT. A SECOND RADIOGRAPH WAS INCLUDED OF A PICC LINE THAT WAS ATTEMPTED TO BE PLACED. A SHORT SEGMENT OF METALLIC WIRE IS SEEN IN THE DISTAL TIP OF THE CATHETER MEASURING 4.3 CM IN LENGTH, POSSIBLY A PORTION OF THE GUIDELINE WHAT WAS REPORTEDLY BROKEN. THE PICC LINE WAS REMOVED AND REPLACED WITH A BARD POWER PICC SOLO CATHETER. FDA SAFETY REPORT ID#: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9192845 ↗
• InjuryJul 25, 2016Insufficient Device Problem Information

  ON 07/07/2016- PER SALES REPRESENTATIVE, FACILITY REPORTED SEVERAL DVTS RECENTLY WITH PICC LINES. ON 7/18/2016 - ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE: THE PATIENT HAD THE PICC PLACED IN THE LEFT UPPER ARM BASILICA. REPORT STATED THAT COMPLETE OCCLUSIVE ACUTE DEEP VENOUS THROMBOSIS WAS NOTED IN THE LEFT BRACHIAL VEIN AFTER SYMPTOMS OF EDEMA WERE NOTED IN THE ENTIRE LEFT ARM. LOVENOX WAS ADMINISTERED FOR THE CLOT AND A DUPLEX SCAN WAS DONE OF THE EXTREMITY VEINS. THE PICC LINE WAS REMOVED AND A PERIPHERAL LINE WAS USED FOR THE REMAINDER OF THE PATIENT'S THERAPY. PATIENT DIAGNOSIS: "KYPHOSCOLIOSIS AND SCOLIOSIS/ INFANTILE CEREBRAL PALSY - THIS ADMISSION WAS FOR POSTERIOR SPINAL IMPLEMENTATION AND FUSION OF T3-SACRUM".

  Patient problems: Edema; Thrombosis

  MAUDE report 5818941 ↗
• InjuryJul 7, 2016Break

  ON 06/30/2016- ADDITIONAL INFORMATION FROM FACILITY CONFIRMED THAT THE GUIDEWIRE FRAGMENT MIGRATED INTO THE LUNG. ON 08/09/2016 - CLARIFICATION RECEIVED FROM FACILITY CONTACT: THE RADIOLOGY REPORT STATES THAT THE SMALL WIRE FRAGMENT IS MOST LIKELY IN A BRANCH OF THE LOWER LOBE PULMONARY ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 5774946 ↗