INFINITI 534552SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032013925), received between Mar 31, 2017 and Jul 14, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 16, 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.

• MalfunctionJul 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE IS A HAIR SEALED IN THE PACKAGE OF A 5F 145-DEGREE 110CM 6 SIDE HOLE (SH) INFINITI DIAGNOSTIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. TWO IMAGES WERE PROVIDED FOR REVIEW: ONE DISPLAYS THE PRODUCT LABELING OF AN INFINITI DIAGNOSTIC CATHETER, AND THE OTHER SHOWS THE CATHETER BODY INSIDE THE POUCH. A HAIR-LIKE FOREIGN BODY IS VISIBLE WITHIN THE PACKAGE, BUT IT IS NOT POSSIBLE TO DETERMINE FROM THE IMAGES ALONE WHETHER THE STERILE BARRIER HAS BEEN COMPROMISED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495643 ↗
• MalfunctionMay 4, 2023Crack; Crack

  AS REPORTED, THE TIP END OF A 5F 110CM ANGLED PIGTAIL 6 SIDE HOLES (SH) INFINITI DIAGNOSTIC CATHETER WAS FOUND FRACTURE. THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS COMPLETED WITH ANOTHER INFINITI CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF CORONARY ARTERY DISEASE AND HAD BEEN ADMITTED TO THE HOSPITAL BECAUSE OF PAIN IN THE PRECORDIAL REGION. ANGIOGRAPHY REVEALED MORE THAN EIGHTY PER-CENT STENOSIS OF THE ANTERIOR DESCENDING BRANCH OF THE LEFT CORONARY, REQUIRING PCI. THE TARGET LESION WAS REPORTED TO BE IN THE BIFURCATION. THERE WAS NO LESION CALCIFICATION OR VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE ACCESS SITE WAS RADIAL. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE AND NO RESISTANCE/FRICTION EXPERIENCED DURING ANY PART OF THE PROCEDURE. NO UNUSUAL FORCE WAS NECESSARY DURING USE OF THE DEVICE AND THERE WAS NO EXCESSIVE TORQUEING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868385 ↗
• InjuryJun 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN RETRACTING THE 5F 110CM 145 INFINITY PIGTAIL WITH 6 SIDEHOLES (SH) DIAGNOSTIC CATHETER OUT OF PATIENT THROUGH FEMORAL APPROACHED, IT WAS NOTED THE TIP WAS ABSENT. THE CATHETER TIP WAS STILL INSIDE PATIENT. THEREFORE, THE VASCULAR SURGEON WAS CALLED TO RETRIEVE THE END OF CATHETER USING A GOOSENECK SNARE. THERE WAS NO HARM TO THE PATIENT. AS PER THE SALES REP ¿RETRIEVAL OF CATHETER TIP WAS SUCCESSFULLY ACHIEVED. PATIENT OUTCOME FINE.¿ IT WAS A ROUTINE CARDIAC PROCEDURE USING INFINITY PIGTAIL DIAGNOSTIC CATHETER. THE INFINITY USER WAS TRAINED. THE DEVICE WAS OPENED IN THE STERILE FIELD. THE DEVICE WAS NOT RE-STERILIZED. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREP. AS PER SALES REP ¿IT WAS NOTED FROM THE ORIGINAL PACKAGING THAT IT HAD NOT BEEN OPENED COMPLETELY. THE CATHETER WAS TAKEN OUT OF PACKAGING WITHOUT OPENING THE PLASTIC COMPLETELY AND REMOVING FROM THE CARDBOARD¿ AND "IT COULD HAVE BEEN KINKED AT THAT JUNCTION POINT WERE IT SNAPPED OFF BECAUSE IT WAS PULLED OUT OF THE PACKAGING WITHOUT OPENING THE CLEAR PACKAGE COMPLETELY". THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. ADDITIONAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130106 ↗
• MalfunctionApr 3, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE F5 INFINITI CATHETER PIG 145 110CM 6SH HUB TWISTED OFF THE CATHETER WHILE THE DEVICE WAS TORQUED. EVERYTHING WAS REMOVED SAFELY FROM THE BODY. THERE WERE NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6454777 ↗
• MalfunctionMar 31, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THERE WERE TWO INFINITI 5F PIG TAIL CATHETERS THAT SEPARATED ABOVE THE HUB JOINT INSIDE THE PATIENT. THE CATHETERS WERE REMOVED FROM THE PATIENT SAFELY BY PULLING THE EXTERNAL PART OF THE CATHETER. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449399 ↗

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