Xcela 45732Recalls & reported problems
Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 5Fx55cm Dual Lumen Catheter MST-70 Kit · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 H965457320), received between May 9, 2023 and May 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Particulates” (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.
Most reported problems
Device problems
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2023Particulates; Particulates
A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM AN XCELA PASV 5F DL 55CM MST-70 KIT. THE PICC HAD BEEN PLACED 7 DAYS PRIOR TO THE REPORTED EVENT FOR A STEM CELL TRANSPLANT THAT HAD YET TO BE PERFORMED. WHILE DRAWING BLOOD, WHITE PARTICLES WERE NOTED IN THE DISPOSABLE SYRINGE, COMING FROM BOTH LUMENS. THE PICC WAS PREVIOUSLY USED ONLY FOR HYDRATION AND FLUSHING/LOCKING FOR MAINTENANCE. THE CATHETER WAS REMOVED AND NEW CATHETER WILL NEED TO BE INSERTED. DUE TO THIS EVENT, THE STEM CELL TRANSPLANT WAS DELAYED UNTIL THE NEW PICC IS PLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895197 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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