PowerPICC SV Catheter with Sherlock Tip Location System (TLS) Stylet 9173108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741035531), received between May 3, 2017 and Oct 19, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT THE THAT PICC LINE WAS LEAKING AND THE LINE NEEDED TO BE EXCHANGED OR REMOVED. PER NOTES IN CHART: (B)(6) 2018 VAT CALLED BECAUSE DRESSING NON-OCCLUSIVE. DRESSING CHANGED AND CATHETER FOUND TO BE OUT 5 CM. LINE FLUSHED BY BEDSIDE RN AND CATHETER NOTED TO BE LEAKING. AFTER SPEAKING WITH PROVIDERS LINE LEFT IN PLACE (BUT NOT USED) SO A DECISION COULD BE MADE TO EXCHANGE OF REMOVE THE LINE. AFTER ID CONSULTED AND IV ANTIBIOTICS CHANGED TO PO, THE LINE WAS REMOVED THE NEXT DAY. ALMOST A COMPLETE BREAK IN CATHETER NOTED AT THE POINT WHERE THE CATHETER JOINS TO THE WINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986115 ↗
• MalfunctionMay 9, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NEEDLE WAS CONTAMINATED WITH AN UNKNOWN DEBRIS THAT "DOESN'T RUB OFF" AND "MAY BE CONTAINED WITHIN THE PLASTIC." KIT WAS NOT USED, AND DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7498716 ↗
• MalfunctionApr 23, 2018Connection Problem

  IT WAS REPORTED THAT A PATIENT WAS RE-ADMITTED WITH A 3FR PICC WHERE THE HUB WAS ALMOST COMPLETELY SEPARATED FROM THE EXTENSION LEG. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450650 ↗
• MalfunctionMar 2, 2018Material Rupture

  IT WAS REPORTED THAT THE DEVICE WAS INSERTED ON (B)(6) 2018. IT WAS STATED AT APPROXIMATELY 6PM THE NEXT DAY, DURING A CONTRAST INJECTION FOR A CT SCAN, THE DEVICE RUPTURED. ACCORDING TO THE RADIOLOGY DOCUMENTATION INDICATED THAT THE RATE ON THE INJECTOR WAS SENT FOR 1 ML/SECOND. THE CATHETER WAS REPORTED TO HAVE FLUSHED EASILY AND HAD BLOOD RETURN PRIOR TO THE POWER INJECTION. CATHETER HAD BEEN USED FOR INTERMITTENT INFUSION OF AMPICILLIN AND CEFAPIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7309620 ↗
• MalfunctionMay 3, 2017Leak/Splash; Material Perforation

  THE FACILITY REPORTED THAT THE PICC PERFORATED BELOW THE SECUREMENT HUB AND BEGAN TO LEAK. NO OTHER INFORMATION AVAILABLE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541943 ↗