Xcela 60M183104Recalls & reported problems
Navilyst Medical, Inc. · PICC Convenience Kit · Class 2 · Implant
Data updated Oct 13, 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 H96560M1831040), received between Jun 24, 2016 and Jun 24, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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
- Detachment Of Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2016Detachment Of Device Component; Detachment Of Device Component
DURING AN IR PICC PLACEMENT PROCEDURE THE RADIOLOGIST WENT TO BREAK THE PEEL-AWAY SHEATH, AND THE TABS BROKE OFF. WHEN THE TABS BROKE OFF, THE SHEATH SLIPPED INTO THE PATIENT'S ARM AND BECAME UNRETRIEVABLE. THEY HAD TO CALL IN A CARDIOVASCULAR SURGEON TO PERFORM A CUTDOWN AND RETRIEVE THE SHEATH.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5748231 ↗
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- 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 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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