TEMPORecalls & reported problems across all models
Cordis Corporation · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 250
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 56 models of TEMPO by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 250 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and Sep 30, 2026 — classified as 41 injuries, 209 malfunctions.
The most frequently reported specific device problem is “Degraded” (74 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. 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
Most reported TEMPO problems
Device problems
- Degraded74
- Detachment of Device or Device Component66
- Crack55
- Device Contamination with Chemical or Other Material20
- Material Puncture/Hole15
- Difficult to Remove9
- Leak/Splash8
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions197
- No Consequences Or Impact To Patient33
- Vascular Dissection7
- Foreign Body In Patient6
- No Known Impact Or Consequence To Patient5
- Device Embedded In Tissue or Plaque4
- No Code Available1
- Obstruction/Occlusion1
TEMPO models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TEMPO 451514H0CATHETER, INTRAVASCULAR, DIAGNOSTIC31 reports
- TEMPO 451503H5CATHETER, INTRAVASCULAR, DIAGNOSTIC16 reports
- TEMPO 451531H0CATHETER, INTRAVASCULAR, DIAGNOSTIC15 reports
- TEMPO 451506P0CATHETER, INTRAVASCULAR, DIAGNOSTIC14 reports
- TEMPO 451414H0CATHETER, INTRAVASCULAR, DIAGNOSTIC13 reports
- TEMPO 451504V5CATHETER, INTRAVASCULAR, DIAGNOSTIC10 reports
- TEMPO 451513H0CATHETER, INTRAVASCULAR, DIAGNOSTIC10 reports
- TEMPO 451404V5CATHETER, INTRAVASCULAR, DIAGNOSTIC9 reports
- TEMPO SRD5559CATHETER, INTRAVASCULAR, DIAGNOSTIC9 reports
- TEMPO 451403V5CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- TEMPO 451415V0CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- TEMPO 451503L5CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- TEMPO 451543V0CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- TEMPO 451543H0CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- TEMPO 451415H0CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- TEMPO 451443V2CATHETER, INTRAVASCULAR, DIAGNOSTIC5 reports
- TEMPO 451431H0CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO 451443V0CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO 451515H0CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO 451524H0CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO 451530H0CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO SRD5602CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- TEMPO 451403F5CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- TEMPO 451406H0CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- TEMPO 451457V0CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- TEMPO 451532H0CATHETER, INTRAVASCULAR, DIAGNOSTIC3 reports
- TEMPO 451401V5CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451406P0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451418S0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451430H0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451435H0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451501H5CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451503F5CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451506H0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451531H2CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451539H0CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO SRD5821CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO SRD6892CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO SRD5601CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- TEMPO 451401L5CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451403H5CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451404F5CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451406V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451413H0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451442V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451442V2CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451443H0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451503V5CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451504L5CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451506V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451507H2CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451507V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451513V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451535H0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO 451542V0CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- TEMPO SRD5497CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent TEMPO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949105 ↗MalfunctionSep 28, 2026Material Frayed; Material Split, Cut or Torn
As reported, the tip of a 4F 100cm Vertebral (VERT) Tempo diagnostic catheter was split. A new 4F 100cm VERT Tempo diagnostic catheter was used as a replacement. There were no reported injuries to the patient. An unknown 4F sheath and unknown J-wire were used during the procedure. The device will be returned for evaluation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914625 ↗MalfunctionAug 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252364 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50025079 ↗MalfunctionApr 17, 2026Crack
AS REPORTED, A 5F 100CM 135-DEGREE VERTEBRAL (VER) TEMPO DIAGNOSTIC CATHETER CRACKED. A SECOND 5F 100CM 135-DEGREE VER TEMPO DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT OR ADVERSE EFFECTS NOTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24916509 ↗MalfunctionApr 4, 2026Detachment of Device or Device Component
AS REPORTED, THE DISTAL END OF THE 5F UF 65CM TEMPO CATHETER BECAME BENT AND DETACHED WHILE ON THE WIRE. THE WIRE, CATHETER AND BROKEN PORTION WAS PULLED OUT OF THE SHEATH WITH NO HARM TO THE PATIENT. THE BREAK OCCURRED WHILE ATTEMPTING TO ADVANCE THE CATHETER UP AND OVER THE ILIAC BIFURCATION. NO UNUSUAL FORCE WAS APPLIED, ALTHOUGH THE ILIAC VESSELS WERE NOTED TO BE TORTUOUS. THE INTENDED PROCEDURE WAS A LEG ANGIOGRAM FOR DISTAL DISEASE. THE LESION HAD LITTLE OR NO CALCIFICATION, AND VESSEL TORTUOSITY WAS PRESENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DEVICES ARE STORED HANGING ON A CATHETER SUPPLY CART AND ARE SOMETIMES KEPT IN PROCEDURE OR SUPPLY AREAS DURING ROOM TURNOVER, WITHOUT EXPOSURE TO OUTDOOR LIGHT OR ADVANCED DECONTAMINATION METHODS SUCH AS UV-C, VHP, OZONE, OR FOGGING. DEVICES ARE REMOVED FROM THE OUTER BOX AND STORED ON HANGERS WITH OTHER CATHETERS, NOT IN CABINETS. STORAGE ENVIRONMENTS ARE CLIMATE CONTROLLED WITH NO KNOWN FACILITY ISSUES (E.G., HVAC, HUMIDITY, LEAKS) OR RECENT CHANGES TO CLEANING OR STORAGE PRACTICES. THE DEVICE IS NOT REPROCESSED OR EXPOSED TO UV OR STERILIZATION PROCESSES. A NON-CORDIS GUIDEWIRE WAS USED. T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784463 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
AS REPORTED, THE HUB OF A 4F BERENSTEIN (BER) 100CM TEMPO DIAGNOSTIC CATHETER BROKE OFF FROM THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24547246 ↗MalfunctionMar 9, 2026Detachment of Device or Device Component
AS REPORTED, A 4F 100CM VERTEBRAL (VERT) 135-DEGREE ANGLE TEMPO DIAGNOSTIC CATHETER SHEARD AT THE HUB DURING AN ANGIOGRAM WITH THE TIP IN THE DESCENDING AORTA. THE CATHETER EXPERIENCED A COMPLETE SEPARATION AT THE JUNCTION BETWEEN THE PROXIMAL CUFF AND THE PROXIMAL SHAFT. THE USER STILL HAD CONTROL OF THE PROXIMAL SHAFT AFTER THE SEPARATION AND WAS ABLE TO REMOVE THE DEVICE. AN UNKNOWN REPLACEMENT CATHETER WAS USED WITHOUT ISSUES, AND THE PROCEDURE WAS COMPLETED NORMALLY. THE PATIENT WAS NOT AT RISK AND THERE WERE NO REPORTED INJURIES AS NO AIR ENTERED THE LUMEN. THE CONTRAST SPRAYED ON TO THE DRAPES AND THERE WAS NO CHANGE OF GAS ENTERING THE CEREBRAL CIRCULATION. THIS WAS DURING AN ANGIOGRAM PERFORMED BY HAND INJECTION WITH LESS THAN 2 ML OF CONTRAST IN A 5 ML SYRINGE AND IT WAS THE FIRST ANGIOGRAM PERFORMED WITH THE TEMPO DIAGNOSTIC CATHETER. THE TARGET VESSEL WAS THE COMMON CAROTID ARTERY, WHICH HAD NO CALCIFICATION OR TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO DAMAGE TO THE DEVICE OR PACKAGING PRIOR TO USE. THERE WAS NO DIFFICULTY ADVANCING THE CATHETER. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545057 ↗MalfunctionMar 6, 2026Detachment of Device or Device Component
AS REPORTED, A 5F 125 CM TEMPO DIAGNOSTIC CATHETER BROKE OFF AT THE HUB DURING EXTRACTION FROM THE SHEATH. THE SEPARATED SEGMENT WAS BROKEN OFF IN THE PATIENT¿S BODY BUT WAS SUCCESSFULLY RETRIEVED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532053 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
AS REPORTED, A 5F SIMMONS (SIM) 1 100CM TEMPO DIAGNOSTIC CATHETER FRACTURED DURING USE, WITH A PORTION OF THE CATHETER BREAKING INSIDE THE BODY. THE BROKEN CATHETER WAS REMOVED USING A SNARE, CAUSING THE PROCEDURE TIME TO BE EXTENDED. THE DISTAL TIP OF THE DEVICE SEPARATED, AND NO ANOMALIES WERE NOTED WHEN IT WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUEING WAS REQUIRED, AND NO RESISTANCE OCCURRED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION, AND NO RESISTANCE WAS MET DURING WITHDRAWAL. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION, WAS NOT RESTERILIZED, AND THE PATIENT¿S CURRENT STATUS IS GOOD. THERE WERE NO OBVIOUS SIGNS OF DEVICE OR PACKAGING DAMAGE PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 24489907 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
AS REPORTED, A 4F 65CM UF TEMPO CATHETER USED IN LEG ANGIOGRAM CASE. THE CATHETER SNAPPED ABOUT 2 INCHES FROM THE TIP DURING REMOVAL FROM THE SHEATH. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER OF THE SAME PRODUCT CODE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO APPARENT DAMAGE NOTED PRIOR TO USE. THERE WAS NO RESISTANCE OR FRICTION WHILE ADVANCING THROUGH THE VESSEL, AND NO UNUSUAL FORCE WAS REQUIRED DURING ADVANCEMENT OR WITHDRAWAL OF THE CATHETER. THE INTENDED PROCEDURE WAS A DIAGNOSTIC LEG ANGIOGRAM, WITH NO LESION PRESENT. THE VESSEL SHOWED NO CALCIFICATION OR TORTUOSITY, AND THERE WAS NO RESISTANCE WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483062 ↗MalfunctionFeb 27, 2026Degraded
AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472532 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
AS REPORTED, THE TIP OF A 5F TEMPO VERTEBRAL (VERT) 100 CM DIAGNOSTIC CATHETER WAS FOUND BROKEN IN THE PATIENT¿S DISTAL INTERNAL CAROTID ARTERY (ICA) DURING MID-USE. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS MET WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUEING WAS REQUIRED, AND NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. NO RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE; HOWEVER, THE DISTAL TIP BROKE, AND ALTHOUGH THERE WAS NO KINK IN THE AREA OF SEPARATION, THE USER HAD TO SNARE IT OUT WITH DIFFICULTY. THE EVENT OCCURRED DURING A DIAGNOSTIC CEREBRAL ANGIOGRAM; THE VESSEL WAS NOT TORTUOUS AND THE CATHETER WAS NOT KINKED. THE LESION WAS NOT CALCIFIED, AND THE DEVICE WAS USED FOR A DIAGNOSTIC CEREBRAL ANGIOGRAM. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PATIENT REMAINED STABLE, THOUGH THE PROCESS WAS PROLONGED DUE TO RETRIEVAL DIFFICULTY. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PROPERLY STORED AND OPENED IN A STERILE FIELD. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WI
Patient problems: Foreign Body In Patient
MAUDE report 24428031 ↗MalfunctionFeb 9, 2026Crack
AS REPORTED, THE CAP AT THE TOP OF A 4F COBRA (C) 1 65CM TEMPO DIAGNOSTIC CATHETER WAS BROKEN WHEN A SYRINGE WAS ATTACHED, WHICH CAUSED LEAKING. THERE WAS NO REPORTED PATIENT INJURY. AS FAR AS THE OPERATOR IS AWARE, THERE WAS NOT ANY EXCESS PRESSURE USED WHICH COULD HAVE CAUSED THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293829 ↗MalfunctionJan 30, 2026Leak/Splash
AS REPORTED, THE HUB OF A 4F SIM 2 100CM TEMPO DIAGNOSTIC CATHETER WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. THE LEAK WAS IDENTIFIED AT THE HUB WHERE THE CATHETER CONNECTS TO THE LUER END AND WAS NOTICED WHEN ATTEMPTING TO PERFORM A HAND INJECTION. A CONTRALATERAL APPROACH WAS NOT USED. THE ACCESS SITE VESSEL WAS DESCRIBED AS NORMAL. THE DEVICE WAS FLUSHED PRIOR TO USE, AND THE SHEATH DILATOR WAS SECURELY CONNECTED AT THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING INSERTION OR WITHDRAWAL. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. NO DEVICE DAMAGE WAS NOTED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. NO UNUSUAL FORCE WAS USED DURING THE PROCEDURE, AND NO DIFFICULTIES WERE ENCOUNTERED WHILE INSERTING OR WITHDRAWING ANY CONCOMITANT DEVICES. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223292 ↗
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 16, 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