TEMPO AQUARecalls & reported problems across all models

We found 6 models of TEMPO AQUA by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jan 30, 2019 and Jun 24, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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

Most reported TEMPO AQUA problems

TEMPO AQUA models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TEMPO AQUA SRD6108

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  12 reports
• TEMPO AQUA SRD6109

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  5 reports
• TEMPO AQUA 452414H0

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• TEMPO AQUA 452514H0

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 reports
• TEMPO AQUA 452413H0

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report
• TEMPO AQUA 452531H0

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  1 report

Recent TEMPO AQUA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, DURING AN INTERVENTIONAL ANGIOGRAM PERFORMED IN THE NORTH ZONE, IT WAS NOTED INTRAOPERATIVELY UNDER ANGIOGRAPHY THAT THE PROXIMAL END OF THE CATHETER WAS KINKED. WHEN THE PROXIMAL CATHETER WAS TURNED, THE DISTAL END COULD NOT BE TURNED WITH IT. THE KINKED CATHETER COULD NOT BE WITHDRAWN AT THAT TIME, AND ATTEMPTS WERE MADE TO ROTATE THE CATHETER IN BOTH DIRECTIONS WHILE TRYING TO WITHDRAW THE KINKED CATHETER BY UNTWISTING IT USING A GUIDEWIRE. THERE WERE NO REPORTS OF PATIENT INJURY. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO CHINA NMPA. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322273 ↗
• MalfunctionMar 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F 100CM VERTEBRAL (VERT) 135-DEGREE CURVE TEMPO AQUA DIAGNOSTIC CATHETER WAS PREPARED AND CONNECTED TO A POWER INJECTOR. THERE WAS PATENT FLOW CONFIRMED. A CONTRAST POWER INJECTION WAS PERFORMED AT 4ML/SECOND FOR 24ML TOTAL WITH 1 SECOND RATE RISE AT 400 POUNDS PER SQUARE INCH (PSI) IN THE RIGHT INTERNAL CAROTID ARTERY. CONTRAST COULD BE SEEN BRIEFLY DURING THE POWER INJECTION AND THEN DISAPPEARED. UPON INVESTIGATION OF THE DEVICE, IT WAS DISCOVERED THAT THE CATHETER WAS SEPARATED. AN IMAGE OF THE CATHETER WAS PROVIDED WHICH SHOWS THE LUER HUB AND STRAIN RELIEF ARE COMPLETELY SEPARATED FROM THE MAIN BODY OF THE CATHETER. A SMALL PORTION OF THE SEPARATED CATHETER WAS STICKING OUT FROM THE PATIENT AND WAS ABLE TO BE IMMEDIATELY CLAMPED AND REMOVED. THERE WERE NO NOTED COMPLICATIONS UPON CHART REVIEW AND NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY FLUSHING THE CATHETER PRIOR TO INSERTION. A 0.035" ANGLED NON-CORDIS HYDROPHILIC GUIDEWIRE WAS USED TO DELIVER THE CATHETER PRIOR TO THE ANGIOGRAM. THERE WAS NO RESISTANCE OR FRICTION BETWEEN THE NON-CORDIS GUIDEWIRE AND CATHETER. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710551 ↗
• MalfunctionMar 7, 2025Crack; Crack

  AS REPORTED, THE HEAD OF THE 5F 125 CM SIDEWINDER II TEMPO AQUA CATHETER WAS FOUND TO BE BENT AND CRACKED, AND RINSING REVEALED LEAKAGE WHEN THE OPERATOR OPENED THE PACKAGE FOR CEREBRAL ANGIOGRAPHY SUPER SELECTIVE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547183 ↗
• MalfunctionJan 17, 2025Crack; Crack

  AS REPORTED, THE TIP OF 5F 125CM TEMPO AQUA CONTRAST CATHETER WAS FOUND TO BE CRACKED AT THE DISTAL END OF THE BODY/SHAFT WHEN OPENING THE PACKAGE. THE DEVICE CRACKED BUT DID NOT SEPARATE INTO TWO SEPARATE PIECES. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER SIM2 CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE, AND THE PRODUCT WAS STORED WITHOUT ANY DAMAGE IN THE LAB. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU), AND NO DIFFICULTY WAS EXPERIENCED DURING THE PREP. THE ACCESS SITE WAS THE RADIAL ARTERY, AND THE INTENDED PROCEDURE WAS FOR CAROTID ARTERY STENOSIS. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181091 ↗
• MalfunctionDec 27, 2024Crack; Degraded; Leak/Splash; Crack; Degraded; Leak/Splash

  AS REPORTED, THE OPERATOR PERFORMED CAROTID SUPER-SELECTION VIA THE RADIAL ARTERY, CHOOSING A 5FR TEMPO AQUA AND PREOPERATIVELY PREPARED TO FLUSH THE FIRST CATHETER. ITS RECURVE/BEND OCCURRED A JET OF WATER. THE FIRST DEVICE HAD A LEAK. THE SECOND 5F TEMPO AQUA CATHETER HAD AN OBVIOUS BREAK/LEAK AS WELL. THE CASE WAS COMPLETED WITH A THIRD CATHETER. THE DEVICES WERE NOT USED IN THE PATIENT. THERE WAS NO REPORTED INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025536 ↗
• MalfunctionDec 27, 2024Crack; Degraded; Leak/Splash; Crack; Degraded; Leak/Splash

  AS REPORTED, THE OPERATOR PERFORMED CAROTID SUPER-SELECTION VIA THE RADIAL ARTERY, CHOOSING A 5FR TEMPO AQUA AND PREOPERATIVELY PREPARED TO FLUSH THE FIRST CATHETER. ITS RECURVE/BEND OCCURRED A JET OF WATER. THE FIRST DEVICE HAD A LEAK. THE SECOND 5F TEMPO AQUA CATHETER HAD AN OBVIOUS BREAK/LEAK AS WELL. THE CASE WAS COMPLETED WITH A THIRD CATHETER. THE DEVICES WERE NOT USED IN THE PATIENT. THERE WAS NO REPORTED INJURY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICES. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025486 ↗
• MalfunctionOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TWO (2) 4F 65CM 5 SIDE HOLES (SH) UNIVERSAL FLUSH (UF) TEMPO CATHETERS WERE SHEARED OFF JUST BELOW THE LAST FLUSH HOLES WHERE IT ATTACHED TO THE ACTUAL SHAFT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS USED IN THE NORMAL MANNER. THE DEVICES WERE STORED IN THE CATH LAB FOR LESS THAN A MONTH. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO EXCESS FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS. THERE IS NO PROCEDURAL CD/ANGIOGRAM/ DEVICE IMAGES AVAILABLE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705498 ↗
• MalfunctionOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TWO (2) 4F 65CM 5 SIDE HOLES (SH) UNIVERSAL FLUSH (UF) TEMPO CATHETERS WERE SHEARED OFF JUST BELOW THE LAST FLUSH HOLES WHERE IT ATTACHED TO THE ACTUAL SHAFT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS USED IN THE NORMAL MANNER. THE DEVICES WERE STORED IN THE CATH LAB FOR LESS THAN A MONTH. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO EXCESS FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS. THERE IS NO PROCEDURAL CD/ANGIOGRAM/ DEVICE IMAGES AVAILABLE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705418 ↗
• MalfunctionJul 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 4F 125CM .038¿ VERTEBRAL (VERT) TEMPO AQUA ANGIOGRAPHIC CATHETER CAME APART INTO 2 PIECES AS THERE WAS A LOT OF STRESS WAS PUT ON IT. THE DEVICE WAS USED IN A HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) ORIGIN. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE DEVICE SEPARATED INSIDE THE PATIENT. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS STORED PER IFU IN THE STOREROOM. THERE WAS MODERATE VESSEL TORTUOSITY. THERE WAS LITTLE VESSEL ANGULATION. THE DEVICE WAS USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RE-STERILIZED. RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS REQUIRED. RESISTANCE WAS NOT MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE WAS KINKED IN THE AREA OF SEPARATION. RESISTANCE WAS MET WHILE WITHDRAWING THE DEVICE. THE PRODUCT WAS NOT REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10322768 ↗
• InjuryApr 15, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  DURING A CEREBRAL ANGIOGRAPHY, THE PHYSICIAN USED A 5F 2 100CM TEMPO AQUA SIDEWINDER SIMMONS TECHNIQUE II (SIM2) ANGIOGRAPHIC CATHETER AND THE CATHETER BROKE INSIDE THE PATIENT. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE AND RESISTANCE MET WHILE WITHDRAWING THE DEVICE BECAUSE THE PATIENT HAD VERY TORTUOUS AND CALCIFIED ARTERIES AND THEREFORE IT WASN¿T EASY TO MOVE THE CATHETER. THE PHYSICIAN REMOVED THE LOST PIECE WITH A SNARE. THE PATIENT IS ALIVE. THE EVENT DID NOT CAUSE A CONDITION THAT REQUIRES HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE. THERE WAS SEVERE CALCIFICATION OF THE LESION. THERE WAS MODERATE VESSEL TORTUOSITY. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THERE IS NO PROCEDURAL CD AVAILABLE FOR REVIEW. OTHER ADDITIONAL PATIENT/PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963797 ↗
• InjuryNov 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER USE OF A CORDIS 4F 100CM BER TEMPO AQUA CATHETER FOR AN ANGIOGRAM INSIDE A PREVIOUSLY PLACED NON-CORDIS ABDOMINAL AORTIC ANEURYSM (AAA) GRAFT, THE CATHETER TIP LODGED BETWEEN THE NON-COVERED STRUTS OF THE AAA GRAFT. THE PHYSICIAN INSERTED A NON-CORDIS WIRE INTO THE TEMPO CATHETER BUT ONLY THE SHAFT OFF THE CATHETER CAME OUT AND THE TIP (APPROX. 3CM IN LENGTH) REMAINED INSIDE PATIENT. HE TRIED FOR SEVERAL HOURS TO REMOVE THE CATHETER TIP BUT WAS UNSUCCESSFUL. THE PATIENT WAS LATER BROUGHT BACK TO INTERVENTIONAL RADIOLOGY AND HAD THE TIP SUCCESSFULLY REMOVED. THE STATUS OF THE PATIENT WAS ¿SAFE¿. THE DEVICE WILL NOT BE RETURNED. NO PROCEDURAL CD WILL BE AVAILABLE FOR REVIEW. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. EXCESSIVE TORQUING WAS REQUIRED AGAINST THE AAA GRAFT. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369371 ↗
• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE LUER LOCK FITTING ON THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER WAS NOT ENGAGING PROPERLY WITH THE SYRINGE AND WAS THUS LEAKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS PERIPHERAL INTERVENTIONS ON THE LEGS. THE LEAKAGE WAS NOTED WHEN FLUSHING THE DEVICE. THE USER CONTINUED TO USE IT AND TRIED TO STOP/MINIMIZE THE LEAKING. NO ADDITIONAL PATIENT OR PROCEDURAL DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890851 ↗
• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE LUER LOCK FITTING ON THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER WAS NOT ENGAGING PROPERLY WITH THE SYRINGE AND WAS THUS LEAKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS PERIPHERAL INTERVENTIONS ON THE LEGS. THE LEAKAGE WAS NOTED WHEN FLUSHING THE DEVICE. THE USER CONTINUED TO USE IT AND TRIED TO STOP/MINIMIZE THE LEAKING. NO ADDITIONAL PATIENT OR PROCEDURAL DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890785 ↗
• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE LUER LOCK FITTING ON THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER WAS NOT ENGAGING PROPERLY WITH THE SYRINGE AND WAS THUS LEAKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS PERIPHERAL INTERVENTIONS ON THE LEGS. THE LEAKAGE WAS NOTED WHEN FLUSHING THE DEVICE. THE USER CONTINUED TO USE IT AND TRIED TO STOP/MINIMIZE THE LEAKING. NO ADDITIONAL PATIENT OR PROCEDURAL DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890745 ↗
• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE LUER LOCK FITTING ON THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER WAS NOT ENGAGING PROPERLY WITH THE SYRINGE AND WAS THUS LEAKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE BEING PERFORMED WAS PERIPHERAL INTERVENTIONS ON THE LEGS. THE LEAKAGE WAS NOTED WHEN FLUSHING THE DEVICE. THE USER CONTINUED TO USE IT AND TRIED TO STOP/MINIMIZE THE LEAKING. NO ADDITIONAL PATIENT OR PROCEDURAL DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890723 ↗

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