TEMPO AQUA SRD6108Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20705032049785), received between Aug 13, 2019 and Jul 24, 2020 — classified as 12 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, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 8890679 ↗
• 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 8890631 ↗
• 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 8890587 ↗
• 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 8890560 ↗
• 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 8890104 ↗
• 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 8889927 ↗
• 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 8889875 ↗