PowerPICC® SV Catheter with Sherlock Tip Location System (TLS) Stylet 9274118Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741028632), received between Mar 2, 2018 and Jun 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY 2 HOURS AFTER WITHDRAWING SUCH LINE AND APPLYING A NEW DRESSING IT WAS FOUND THAT THE NEW DRESSING AS WELL AS THE ANTIMICROBIAL DISC WAS SATURATED. THE NEW DRESSING WAS THEN REMOVED BY THE SAME FELLOW AND THE LINE WAS THEN FLUSHED TO BE INSPECTED. IT WAS FOUND THAT THERE SEEMED TO BE MULTIPLE OPENINGS IN THE CENTRAL LINE THAT WERE LEADING TO LEAKAGE. BOTH PORTS WERE FLUSHED AND THERE ONLY SEEMED TO HAVE LEAKAGE PRESENT FROM THE PURPLE PORT ON THE POWER PICC. NO APPARENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535571 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, PICC FRACTURE. CATHETER REPLACED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128533 ↗
• MalfunctionApr 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED UNABLE TO FLUSH BOTH LUMENS POST TPA. CXR COMPLETED AND CONFIRMED A KINK IN PICC IN ARM. PICC REPOSITIONED BACK 2 CM AND FUNCTIONAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757250 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC OCCLUDED ON (B)(6) 2018 AND PICC REMOVED. KINK FELT AND SEEN AT 10 CM MARK. ADD INFO RCVD (B)(6) 2021: EXPLANT DATE: (B)(6) 2018. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK CATHETER STABILIZATION DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744847 ↗
• MalfunctionApr 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THE PICC WAS INSERTED (B)(6) 2017 AND OCCLUDED (B)(6) 2017. XRAY SHOWED KINK AND RESOLVED WITH ARM MANIPULATION AND PICC ADJUSTMENT. KINK NOTED. INFO RCVD 04/13/2021. EXPLANT DATE: (B)(6) 2018. WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED: STATLOCK CATHETER STABILIZATION DEVICE WAS THERE PATIENT HARM REPORTED?: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744845 ↗
• MalfunctionApr 28, 2020Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT PT HAD PICC INSERTED (B)(6) 2018. BY (B)(6) PICC WAS REMOVED, FOR REPEATED PROBLEMS WITH IV FLUIDS INFUSING WHEN PATIENT BENT RIGHT ARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10008066 ↗
• MalfunctionApr 12, 2018Break; Detachment Of Device Component

  FACILITY REPORTED TO THE SALES REP THAT THE GUIDEWIRE BROKE. NO OTHER INFORMATION WAS REPORTED, BUT HAS BEEN REQUESTED. 4/2/2018 - ADDITIONAL INFORMATION REPORTED THAT THE INNER AND OUTER WIRES BROKE OFF WHILE IN THE PATIENT. X-RAY WAS DONE AND BREAK WAS CONFIRMED, GUIDEWIRE WAS REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427498 ↗
• MalfunctionMar 2, 2018Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT TPA HAD BEEN INFUSED INTO THE PATIENT'S PICC. UPON REMOVAL OF TPA, THE LUMEN OF THE PICC WAS ALLEGEDLY CRACKED. BLOOD AND NORMAL SALINE FLUSH WAS LEAKING OUT OF THE CRACKED LUMEN. PICC WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311516 ↗