PRODUCT CODE FPA
Set, Administration, Intravascular
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Reporting increase · investigate. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
91,610Prior 90 days: 49,702Injury reports
30,714Source-classified event typeDeath reports
347Reported relationship is unverifiedReporting change
84.3%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 60,506. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
Inset Guard
Read FDA report 50515053 ↗Received 2026-08-31 · Malfunction
Patient problems: Pain
Device problems: Leak/Splash
Inset Guard
Read FDA report 50515098 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Loss of or Failure to Bond; Premature Separation
Inset Guard
Read FDA report 50515099 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Loss of or Failure to Bond; Premature Separation
Inset Guard
Read FDA report 50515100 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Loss of or Failure to Bond; Premature Separation
Inset Guard
Read FDA report 50515101 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Loss of or Failure to Bond; Premature Separation
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.