INFINITIRecalls & reported problems across all models
Cordis Corporation · 22 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one INFINITI model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 144
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 22 models of INFINITI by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 144 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2017 and Sep 30, 2026 — classified as 7 injuries, 137 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (79 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
INFINITI recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 26, 2023Class IOpen, Classified
Non-sterile product labeled as sterile was distributed.
Z-0286-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported INFINITI problems
Device problems
- Detachment of Device or Device Component79
- Degraded28
- Crack9
- Device Contamination with Chemical or Other Material7
- Difficult to Open or Remove Packaging Material6
- Material Puncture/Hole6
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions131
- No Consequences Or Impact To Patient8
- Hypersensitivity/Allergic reaction2
- No Known Impact Or Consequence To Patient1
- Perforation of Vessels1
- Vasoconstriction1
INFINITI models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INFINITI 534642TCATHETER, INTRAVASCULAR, DIAGNOSTIC71 reports
- INFINITI CP0208CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- INFINITI 534518TCATHETER, INTRAVASCULAR, DIAGNOSTIC18 reports
- INFINITI 534570TCATHETER, INTRAVASCULAR, DIAGNOSTIC8 reports
- INFINITI 534521TCATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- INFINITI 534550SCATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- INFINITI 534552SCATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- INFINITI 534560TCATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- INFINITI 534645TCATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- INFINITI 534650SCATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- INFINITI 538453SCATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- INFINITI 534517TCATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- INFINITI 534543TCATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- INFINITI 538418CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- INFINITI 538460CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- INFINITI 538476CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- INFINITI 534554SCATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- INFINITI 534617TCATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- INFINITI 534643TCATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- INFINITI 538493CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- INFINITI CP0210CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- INFINITI SRD5217CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent INFINITI adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE WAS LOCATED AT THE BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING PRIOR TO USE. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. PRIOR TO OBSERVING THE FRACTURE, THE PREPARATION STEP PERFORMED WAS SHAPING THE TIP. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690080 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE WAS LOCATED AT THE BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING PRIOR TO USE. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689975 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689916 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689821 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689742 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689714 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689671 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING AND SHAPING THE TIP DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689626 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689509 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689446 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689385 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
AS REPORTED, A FRACTURE WAS FOUND ON A 6F 100CM MULTIPURPOSE (MPA) 2 INFINITI DIAGNOSTIC CATHETER IMMEDIATELY UPON OPENING THE PACKAGE. THE DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE FRACTURE OCCURRED AT THE BODY NEAR THE TIP AND RESULTED IN A COMPLETE SEPARATION OF THE DEVICE. ANOTHER 6F 100CM MPA 2 INFINITI DIAGNOSTIC CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PREPARATION STEPS WERE PERFORMED PRIOR TO OBSERVING THE FRACTURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE DEVICE WAS STORED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE PACKAGING PRIOR TO USE; HOWEVER, DAMAGE WAS IDENTIFIED AFTER REMOVAL OF THE CATHETER FROM THE STERILE PACKAGING DURING PREPARATION. THE CATHETER WAS REMOVED TOGETHER WITH THE CARDBOARD HOLDER. THE FRACTURE OCCURRED AT THE CATHETER BODY NEAR THE TIP AND RESULTED IN COMPLETE SEPARATION OF THE DEVICE. ANOTHER MPA (534642T) WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689316 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
AS REPORTED, THE 6F MP A2 INFINITI ANGIOGRAPHY CATHETER BROKE INTO THREE PIECES AS SOON AS IT WAS TAKEN OUT, SO WE REPLACED IT WITH ANOTHER CATHETER AND CONTINUED USING IT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663688 ↗MalfunctionMar 12, 2026Detachment of Device or Device Component
AS REPORTED, TWO 6F MULTIPURPOSE (MP) A2 100CM INFINITI THRULUMEN DIAGNOSTIC CATHETER BROKE DURING SHAPING. THE STRAIN RELIEF PORTION OF THE DEVICE BROKE DURING SHAPING, RESULTING IN A FRACTURE AND SEPARATION INTO MULTIPLE PIECES. THE SURGEON IMMEDIATELY STOPPED USING THE CATHETERS AND REPLACED THEM WITH ANOTHER NON-CORDIS CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED DURING A PATENT DUCTUS ARTERIOSUS (PDA) SURGICAL PROCEDURE AFTER AN UNKNOWN GUIDEWIRE HAD BEEN REMOVED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). SHAPING WAS PERFORMED OUTSIDE OF THE PATIENT, AND THE BREAKAGE ALSO OCCURRED OUTSIDE OF THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA.ADDENDUM: BOTH DEVICES WERE RETURNED WITH SEPARATIONS AT THE DISTAL TIP AND THE STRAIN RELIEFS FULLY INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24583488 ↗
Other Cordis Corporation products
All Cordis Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page