INFINITI 538450SRecalls & reported problems
Cordis US Corp. · CATH F4 INF PIG 110CM 6SH · Class 2
All models of INFINITI (20)
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 10705032014823), received between Mar 14, 2019 and Sep 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Degraded” (2 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.
Reports received per month
Most reported problems
Device problems
- Degraded2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50577234 ↗MalfunctionSep 2, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573680 ↗MalfunctionMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, WHEN ADVANCING THE GUIDEWIRE INTO A 4F INFINITI (110CM 6SH) PIGTAIL CATHETER, THE PIGTAIL END BROKE OFF. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8421456 ↗
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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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