Xcela 45668Recalls & reported problems
Navilyst Medical, Inc. · Xcela Power Injectable PICC - 6Fx55cm 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M001456680), received between Mar 10, 2017 and Mar 23, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2017Fracture; Fracture
AS REPORTED, TABS BROKE OFF PEELABLE SHEATH PACKAGED WITH XCELA PICC. END USER USED HEMOSTATS TO PULL THE SHEATH OUT OF THE PATIENT. NO PATIENT INJURY OCCURRED. THE USED SHEATH HAS BEEN RETURNED TO ANGIODYNAMICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6428486 ↗MalfunctionMar 23, 2017Fracture; Fracture
AS REPORTED, TABS BROKE OFF PEELABLE SHEATH PACKAGED WITH XCELA PICC. END USER USED HEMOSTATS TO PULL THE SHEATH OUT OF THE PATIENT. NO PATIENT INJURY OCCURRED. THE USED SHEATH HAS BEEN RETURNED TO ANGIODYNAMICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6428466 ↗MalfunctionMar 10, 2017Fracture; Fracture
AS REPORTED, TABS BROKE OFF PEELABLE SHEATH PACKAGED WITH XCELA PICC. END USER USED HEMOSTATS TO PULL THE SHEATH OUT OF THE PATIENT. NO PATIENT INJURY OCCURRED. THE USED SHEATH HAS BEEN RETURNED TO ANGIODYNAMICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6396565 ↗
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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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