INFINITI 538420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032014601), received between Dec 10, 2024 and Nov 23, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PROXIMAL END OF A 4F JUDKIN¿S LEFT (JL) 4.0 100 CM INFINITI DIAGNOSTIC CATHETER WAS FOUND BROKEN AND COULD BE PLUGGED IN AND OUT REPEATEDLY, SUGGESTING IT WAS NOT PROPERLY CONNECTED. THERE WAS NO REPORTED PATIENT INJURY. THE CONDITION OF THE LUER HUB MATCHED WHAT WAS SHOWN IN THE VIDEO. NO DAMAGE WAS OBSERVED ON THE DEVICE OR PACKAGING BEFORE OPENING. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. NO PATIENT INJURY WAS REPORTED IN THE ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETED USING ANOTHER ANGIOGRAPHIC CATHETER. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627925 ↗
• MalfunctionJan 16, 2025Crack; Crack

  AS REPORTED, THERE WAS A CRACK AT THE LUER LOCK CONNECTION OF A 6 F INIFINITI JUDKINS LEFT (JL) 4 100 CM DIAGNOSTIC CATHETER. THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REMOVED FROM THE PACKAGING AND WAS FLUSHED WITH SALINE WHEN IT WAS NOTICED THAT THERE WAS LEAKING FROM SYRINGE. THE DEVICE NEVER ENTERED PATIENT. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE USER IS TRAINED TO THE DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER WITH AN UNKNOWN CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175680 ↗
• InjuryDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895929 ↗