Xcela 75001Recalls & reported problems
Navilyst Medical, Inc. · Xcela Power Injectable PICC - 4F x 55cm Catheter Maximal Barrier Nursing Kit · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H965750010), received between Oct 9, 2024 and Oct 9, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2024Fracture; Fracture
A SPECTRUM MEDICAL TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH AN XCELA 4FSL-55CM MAXIMAL BARRIER NURSING KIT . THE FOLLOWING WAS REPORTED: "SINGLE LUMEN PICC INSERTED 8/27/24 FOR VANCOMYCIN ADMINISTRATION. RIGHT UPPER ARM BASILIC VEIN USED, VESSEL DIAM 3.1MM, CVR APPROX 42%, INSERTION UNCOMPLICATED AND 1 ATTEMPT. CATHETER PERFORMED WITHOUT ISSUE FOR DURATION OF THERAPY. UPON REMOVAL OF CATHETER, RN EXPERIENCED SIGNIFICANT RESISTANCE. SURGEON WAS CONTACTED. APPROX AN HOUR WAS WAITED UNTIL NEXT REMOVAL ATTEMPT. NO WARM PACKS WERE TRIED. NO ANTI-ANXIETY MEDS WERE GIVEN. THE SURGEON TRIED AND EXPERIENCED THE SAME FINDING: SEVERE RESISTANCE. TOOK THE PATIENT TO A PROCEDURE ROOM FOR REMOVAL USING LIVE ULTRASOUND, FLUOROSCOPY, AND A 0.018 GUIDEWIRE. CATHETER WAS EVENTUALLY REMOVED (SNAPPED IN TWO DUE TO ALL THE PULLING AND RESISTANCE). ENTIRE CATHETER WAS RETRIEVED/REMOVED. CATHETER REMOVED WITH SIGNIFICANT RESISTANCE THE ENTIRE LENGTH OF THE VEIN. NO CLOT OBSERVED, CATHETER LUMEN OPEN/PATENT, NO KINKS OBSERVED ON ULTRASOUND OR FLURO. PT HAD A VENOGRAM POST PROCEDURE AND IT WAS NORMAL. IT WAS EITHER COMPLETED RIGHT AFTER THE PROCEDURE AND/OR APPROX 1 WEEK POST REMOVA
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20407382 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.