INFINITI 534554SRecalls & reported problems
Cordis Corporation · CATH F5 INF PIG155 110CM 6SH · Class 2
All models of INFINITI (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032013949), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K970854); they may or may not involve this specific model.
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
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946147 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K970854. One submission often covers many models, so check the product and lot details in each record.
- Z-0286-2024 · Sep 26, 2023 · Open, ClassifiedCordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
- Z-0720-2023 · Nov 7, 2022 · Open, ClassifiedCordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
- Z-1240-06 · Jun 26, 2006 · TerminatedCordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T
Other CATHETER, INTRAVASCULAR, DIAGNOSTIC devices
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- Dragonfly™ OPTIS™ C408646Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 deaths150 reports
- Dragonfly OpStar™ 1014651Lightlab Imaging, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall87 reports
- LANGSTON IPN913559Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls14 reports
- Trevo 90238Stryker Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls5 reports
- Expo™ H749085263011Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls3 reports
- Expo™ H74908526501Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls1 report
- Expo™ H74908526031Boston Scientific Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 recalls0 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.
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