Xcela 45733Recalls & reported problems
Navilyst Medical, Inc. · Xcela PICC with PASV Valve Technology - 5Fx55cm Dual Lumen Catheter IR-145 Kit · Class 2 · Implant
All models of Xcela (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H965457330), received between Apr 6, 2016 and Apr 6, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (2 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 16, 2026.
Most reported problems
Device problems
- Backflow2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2016Backflow; Backflow
AS REPORTED, AFTER PLACING A DUAL LUMEN PICC LINE, THE VALVE ON ONE OF THE LUMENS ALLOWED BLOOD TO COME BACK. THE PICC LINE WAS REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5551882 ↗MalfunctionApr 6, 2016Backflow; Backflow
AS REPORTED, AFTER PLACING A DUAL LUMEN PICC LINE, THE VALVE ON ONE OF THE LUMENS ALLOWED BLOOD TO COME BACK. THE PICC LINE WAS REPLACED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5551878 ↗
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- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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