INFINITI 538421Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032014618), received between Apr 19, 2018 and Aug 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F 100 CM JUDKINS RIGHT (JR4) INFINITI DIAGNOSTIC CATHETER BROKE IN HALF DURING INJECTION. THE DEVICE SEPARATED WHILE HOOKING UP TO THE INJECTOR, OCCURRING IN THE PATIENT BUT EXTERIOR TO THE BODY, ALLOWING IT TO BE SIMPLY REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT. THE INTENDED PROCEDURE WAS REPORTED TO BE A LEFT HEART CATHETERIZATION (LHC), WHICH WAS COMPLETED USING ANOTHER INFINITI CATHETER, AND NO CONTRALATERAL APPROACH WAS USED. THE VESSEL CHARACTERISTICS AT THE TARGET SITE WERE NORMAL, WITH NO CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLE, OR BIFURCATION NOTED. THE ACCESS SITE WAS THE RIGHT RENAL ARTERY (RRA), ALSO WITHOUT CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLE, OR BIFURCATION. THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB, NOR WAS IT TORQUED OR STEERED BY THE HUB. NO DIFFICULTIES WERE ENCOUNTERED IN INSERTING, ADVANCING, OR WITHDRAWING THE DEVICE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DEVICE DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM STERILE PACKAGING, AND IT WAS PREPPED PER THE IFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852067 ↗
• MalfunctionJan 19, 2024Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  AS REPORTED, THE HUB OF A 4F 100CM JUDKINS RIGHT (JR) 4 INFINITI DIAGNOSTIC CATHETER WAS CRACKED AND LEAKING WHEN FLUSHED. THERE WERE NO REPORTED INJURIES TO THE PATIENT AND THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545618 ↗
• MalfunctionApr 13, 2023Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 4F JUDKINS RIGHT JR 4 100CM INFINITI DIAGNOSTIC CATHETER WAS FOUND CRACKED DURING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731560 ↗
• MalfunctionFeb 15, 2019Material Puncture/Hole; Material Puncture/Hole

  BEFORE USE IN THE PATIENT A 4F JR 4 INFINITI CATHETER WAS LEAKING. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED. A PHOTOGRAPH PROVIDED SHOWS A PUNCTURE OF THE DEVICE. THE DEVICE PREPPED FOLLOWING IFU INSTRUCTIONS. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345245 ↗
• InjuryApr 19, 2018Detachment Of Device Component; Detachment Of Device Component

  DURING A DIAGNOSTIC PROCEDURE, IT WAS REPORTED THAT THE DISTAL TIP OF THE INFINITI CATHETER FELL OFF INTO THE PATIENT. THE TIP OF THE CATHETER WAS NOT REMOVED FROM PATIENT. THE PATIENT IS IN STABLE CONDITION. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO ANOMALIES NOTED DURING PREP. THERE WAS NO DIFFICULTY TRACKING THE DEVICE TOWARDS THE LESION. THERE WERE NO KINKS OBSERVED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED DURING THE PROCEDURE. THERE WAS NO DIFFICULTY WITHDRAWING THE DEVICE FROM THE PATIENT. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Injury

  MAUDE report 7443235 ↗