Xcela 25106Recalls & reported problems
Navilyst Medical, Inc. · Xcela Power Injectable PICC - 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
- 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 H965251060), received between Jun 6, 2016 and Jun 22, 2016 — 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.
MalfunctionJun 22, 2016Fracture; Fracture
AS REPORTED, THE EXTENSION TUBING OF AN INDWELLING PICC LINE FRACTURED NEAR THE HUB. THE PICC WAS REMOVED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5742786 ↗MalfunctionJun 6, 2016Fracture; Fracture
AS REPORTED, THE EXTENSION TUBING OF AN INDWELLING PICC LINE FRACTURED NEAR THE HUB, CAUSING LEAKAGE. THE PICC WAS REMOVED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5700634 ↗MalfunctionJun 6, 2016Fracture; Fracture
AS REPORTED, THE EXTENSION TUBING OF AN INDWELLING PICC LINE FRACTURED NEAR THE HUB, CAUSING LEAKAGE. THE PICC WAS REMOVED AND REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5700628 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- 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
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page