Xcela 60M033561Recalls & reported problems
Navilyst Medical, Inc. · PICC Convenience Kit · Class 2 · Implant
All models of Xcela (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H74960M0335610), received between Mar 13, 2017 and Mar 13, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Malposition of Device1
- Positioning Problem1
Patient problems
- Ischemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2017Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem
INFORMATION AS RECEIVED FROM END USER HOSPITAL: " A PICC LINE WAS PLACED IN PATIENT'S RIGHT ARM SEVERAL HOURS LATER THE ARM WAS COLD AND PULSELESS. IT WAS DETERMINED THAT THE PICC WAS NOT IN AN APPROPRIATE PLACEMENT. SURGERY WAS RECOMMENDED BY DECLINED BY PATIENT'S HUSBAND. X-RAY TAKEN ON (B)(6) 2017 INITIALLY CONFIRMED APPROPRIATE PLACEMENT. VENOUS BLOOD GASES TAKEN ON (B)(6) 2017 REVEALED OXYGEN LEVEL OF 135 RAISING SUSPICION OF MALPLACEMENT OF THE PICC." PATIENT'S PAST MEDICAL HISTORY INCLUDED: " HYPERTENSION, HYPERLIPIDEMIA, CVA, CAD, AAA, PAD, PRIOR STEMI AND CHRONIC ALCOHOL ABUSE." THE CATHETER IS BELIEVED TO STILL BE IMPLANTED IN THE PATIENT.
Patient problems: Ischemia
MAUDE report 6399378 ↗
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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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