INFINITI 534570TRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705032013994), received between Jun 20, 2025 and Jun 23, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Degraded” (8 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH A CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION AND ARE STILL IN THE STERILE PACKAGING. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306487 ↗
• MalfunctionJun 23, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH A CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION AND ARE STILL IN THE STERILE PACKAGING. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306431 ↗
• MalfunctionJun 23, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH A CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION AND ARE STILL IN THE STERILE PACKAGING. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306379 ↗
• MalfunctionJun 23, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH A CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION AND ARE STILL IN THE STERILE PACKAGING. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306334 ↗
• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB WHILE STILL IN THE PACKAGING. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH THE CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301741 ↗
• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB WHILE STILL IN THE PACKAGING. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH THE CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301647 ↗
• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB WHILE STILL IN THE PACKAGING. IT IS POSSIBLE THAT UV LIGHT EXPOSURE OCCURRED THROUGH THE CRACK IN THE CABINET. THE ONLY CATHETERS AFFECTED WERE THOSE HANGING ON THE MIDDLE RACK, WHICH WAS ALIGNED WITH THE CABINET OPENING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION. THERE WAS NO VISIBLE PACKAGING DAMAGE. NO PHOTOGRAPHS ARE AVAILABLE. THE DEVICES WERE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301598 ↗
• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, FOUR (4) 5F 100 CM INFINITI RIGHT CORONARY BYPASS (RCB) DIAGNOSTIC CATHETERS DETERIORATED NEAR THE HUB WHILE STILL IN THE PACKAGING. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETERS WERE STORED IN A CABINET WITH ULTRAVIOLET (UV) PROTECTION. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301463 ↗

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, Classified
  Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
• Z-0720-2023 · Nov 7, 2022 · Open, Classified
  Cordis 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 · Terminated
  Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T