TEMPO 451414H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705032007856), received between Feb 7, 2020 and Sep 28, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionAug 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913309 ↗
• MalfunctionJan 31, 2023Crack; Crack

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE A CRACK WAS FOUND AT THE CONNECTION OF A 4F VERTEBRAL (VERT) 135 DEGREE 100CM TEMPO DIAGNOSTIC CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT FOR PROSTATIC HYPERPLASIA, AND WAS GIVEN INTERVENTIONAL TREATMENT AFTER COMPLETING RELEVANT AUXILIARY EXAMINATIONS. THE MEDICAL STAFF OPENED THE DEVICE ACCORDING TO THE REGULAR OPERATION. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275148 ↗
• MalfunctionJan 23, 2023Crack; Crack

  AS REPORTED, THE ANTERIOR SEGMENT OF THE 4F 0.038IN X 100CM TEMPO VERTEBRAL COATED NYLON DIAGNOSTIC CONTRAST CATHETER WAS FOUND TO BE "DEHISCENT" WHEN BEING WITHDRAWN AFTER BEING USED FOR CONTRAST AND PLACEMENT. THE CONTRAST CATHETER WAS REPLACED AND THE "CONTRAST WAS GOOD". THERE WERE NO REPORTS OF PATIENT INJURY. HOWEVER, THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. THE PATIENT HAD BEEN DIAGNOSED WITH LEFT ILIAC VEIN OCCLUSION AND LEFT LOWER EXTREMITY VEIN THROMBOSIS. THE PROCEDURE THAT THE PATIENT HAD TO UNDERGO WAS INFERIOR VENA CAVA FILTER PLACEMENT, LEFT ILIAC VEIN BALLOON DILATION, AND LEFT ILIAC VEIN STENT PLACEMENT AS PRESCRIBED BY THE DOCTOR. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222999 ↗
• MalfunctionJan 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, DURING THE USE OF A 4F 100CM 135-DEGREE TEMPO VERTEBRAL DIAGNOSTIC CATHETER, AN ATTEMPT TO CONNECT A 10MM SYRINGE TO THE CATHETER WAS MADE BUT IT WASN¿T A TIGHT FIT. A SECOND 10MM SYRINGE WAS USED TO CONNECT BUT THE SAME ISSUE OCCURRED. AS A RESULT, THE DEVICE WAS RECALLED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN WHICH A CONTRALATERAL APPROACH WAS USED. 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 16214680 ↗
• MalfunctionJan 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THERE WAS RESISTANCE WHEN ATTACHING THE SYRINGE TO THE HUB OF TWO 4F TEMPO VERTEBRAL 100CM DIAGNOSTIC CATHETERS. IT WAS NOTICED THAT THE SYRINGE HAD RESISTANCE CONNECTING TO THE HUB DURING PREP. ANOTHER UNKNOWN VERTEBRAL CATHETER WAS OPENED AND WORKED FINE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INSPECTED IN THE PACKAGE PRIOR TO OPENING. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS OPENED IN A STERILE FIELD. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE WAS STORED PER LABELING. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16084116 ↗
• MalfunctionOct 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THERE WAS RESISTANCE WHEN ATTACHING THE SYRINGE TO THE HUB OF A 4F TEMPO VERTEBRAL 100CM DIAGNOSTIC CATHETER. IT WAS NOTICED THAT THE SYRINGE HAD RESISTANCE CONNECTING TO THE HUB DURING PREP. ANOTHER UNKNOWN VERTEBRAL CATHETER WAS OPENED AND WORKED FINE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INSPECTED IN THE PACKAGE PRIOR TO OPENING. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE WAS OPENED IN A STERILE FIELD. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE WAS STORED PER LABELING. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691404 ↗
• MalfunctionSep 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  AS REPORTED, THE HUB OF A 4F VERTEBRAL TEMPO CATHETER APPEARED FAULTY; IN THAT IT WAS INCREDIBLY DIFFICULT TO ATTACH A LUER LOCK SYRINGE TO THE END OF IT WITHOUT SHEARING OFF ANY PLASTIC. THE FAILURE OCCURRED DURING PREP. THERE WAS NO REPORT PATIENT INJURY. THIS WAS A NEUROCOILING CASE. THE DEVICE WAS STORED, HANDLED, AND PREPPED AS PER INSTRUCTIONS FOR USE (IFU). THERE DEVICE WAS INSPECTED PRIOR TO USE FOR DAMAGES AND THERE WERE NO DAMAGES NOTED AT THAT TIME. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15480302 ↗
• MalfunctionMar 1, 2021Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE COMPETITOR'S COIL CATHETER GOT DETACHED INSIDE THE CATHETER AND THE PHYSICIAN ATTEMPTED TO PUSH THE COIL WITH A COIL PUSHER; HOWEVER, THE COMPETITOR'S COIL PIERCED A PART OF A 4F VERTEBRAL 135 DEGREES 100CM TEMPO CATHETER. IT HAPPENED AROUND 3CM FROM THE DISTAL END OF THE TEMPO CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THE TEMPO CATHETER WAS USED TO EMBOLIZE THE UPPER LEFT BUTTOCK WHICH HAS TORTUOSITY ON THE ACCESS ROUTE AND NO CALCIFICATION. THE DEVICE WAS HANDLED AND STORED WITH ACCORDANCE TO THE INSTRUCTION FOR USE. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCTS FROM THE PACKAGING. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THERE WAS NO EXCESSIVE FORCE USED AT ANY TIME DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396120 ↗
• MalfunctionFeb 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HEAD-END OF THE 4F 100CM VERTEBRAL (VER) 135-DEGREE TEMPO ANGIOGRAPHIC CATHETER FELL OFF. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS DIAGNOSED WITH VARICOSE VEINS OF THE LEFT LOWER EXTREMITY AND ILIAC VEIN COMPRESSION. THE LEFT LOWER EXTREMITY VENOGRAPHY WAS PERFORMED. AFTER THE RIGHT FEMORAL VEIN WAS PUNCTURED, THE USER INSERTED A 5F SHEATH (UNKNOWN) AND A 4F SINGLE CATHETER (UNKNOWN), AND THE LATERAL ILIAC VEIN WAS TURNED OVER. WHEN THE LEFT ILIAC VEIN WAS COMPRESSED, THE HEAD-END OF THE CATHETER FELL OFF. THE HEAD-END FROM 3CM OF THE TEMPO CATHETER WAS SEPARATED BUT THE CATHETER WAS NOT SEPARATED FROM THE GUIDEWIRE (UNKNOWN). IT WAS ALSO MENTIONED THAT AFTER THE LEFT FEMORAL VEIN WAS PUNCTURED, THE USER PLACED IN THE 8F SHEATH (UNKNOWN) AND THE GUIDEWIRE WAS INSERTED INTO THE 8F SHEATH. THE CATHETER WAS PUSHED OUT OF THE SHEATH. THERE WERE NO OBVIOUS COMPLICATIONS. IMAGES RECEIVED WERE REVIEWED. THE FIRST IMAGE IS A PHOTO OF A MONITOR SCREEN. IT SHOWS AN IMAGE OF THE LEFT FEMORAL HEAD IN THE LOWER RIGHT, WITH A SHEATH CANNULA PROJECTING UPWARDS FROM THE LOWER RIGHT EDGE. AN UNKNOWN WIRE APPEARS TO BE ATTEMPTING TO CANNULATE THE SHEATH DISTALLY. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264821 ↗
• MalfunctionJun 10, 2020Crack; Crack

  AS THE PHYSICIAN WAS READY TO PERFORM THE ANGIOGRAPHIC INTERVENTIONAL PROCEDURE AND INSPECT THE 4F 100CM VERTEBRAL (VER) 135 DEGREE TEMPO CATHETER, IT WAS FOUND THAT THE MIDDLE OF THE CATHETER WAS FRACTURED UPON REMOVAL OF THE PACKAGING. THEREFORE, THE PHYSICIAN USED ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELLING. THE DEVICE WAS STORED IN THE CATH LAB ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET LESION WAS THE RIGHT FEMORAL ARTERY. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. THERE WAS NO STENOSIS AND THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT FRACTURED INTO SEPARATE PIECES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138799 ↗
• MalfunctionFeb 7, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING A CEREBRAL ANGIOGRAPHIC EXAMINATION, A 4F TEMPO CATHETER WAS NOTED TO HAVE A PINHOLE AT ITS MIDDLE TIP CAUSING LEAKAGE OF BLOOD AND CONTRAST. THERE WAS NO REPORTED PATIENT INJURY. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681398 ↗