TEMPO 451503H5Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705032008273), received between Oct 27, 2020 and Sep 30, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 16 most recent of 16 reports, 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 ↗
• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025079 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility

  AS REPORTED, THE PORT OF A 5F PIG 100CM TEMPO DIAGNOSTIC CATHETER WAS FOUND TO BE UNEVEN AND COULD NOT CONNECT TO THE Y-CONNECTOR WHILE PREPARING TO PERFORM A PROCEDURE. THE CATHETER WAS IMMEDIATELY REPLACED, AND THE REPLACEMENT FUNCTIONED NORMALLY. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE DELAYED THE PATIENT¿S TREATMENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO THE CHINA NMPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097399 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PROXIMAL SEGMENT OF THE TUBING OF A 5F 100CM 5 SIDE HOLE (SH) PIGTAIL (PIG) TEMPO ANGIOGRAPHIC CATHETER WAS FOUND TO BE INCOMPLETE BEFORE THE PATIENT'S INTERVENTIONAL PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO THE CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) AS AN ADVERSE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553547 ↗
• MalfunctionJul 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, THE PRODUCT PACKAGING OF THE 5F 100CM 5 SIDE-HOLE (SH) PIGTAILED TEMPO DIAGNOSTIC CATHETER WAS DAMAGED, AFFECTING STERILITY. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630693 ↗
• InjuryJun 24, 2025Difficult to Remove; Difficult to Remove

  AS REPORTED, THE 5F 100CM PIGTAILED TEMPO DIAGNOSTIC CATHETER DID NOT PASS SMOOTHLY DURING THE PROCEDURE. THE CATHETER WAS REPEATEDLY INTRODUCED SEVERAL TIMES IN THE RIGHT COMMON FEMORAL VEIN AND SAPHENOUS VEIN, AND A KINK OCCURRED IN THE TEMPO CATHETER AT THE PROXIMAL END OF THE LEFT FEMORAL VEIN PUNCTURE SHEATH. THE NEXT OPERATION COULD NOT BE PERFORMED. IN ORDER NOT TO DELAY THE PATIENT'S TREATMENT, THE EXTRACORPOREAL SECTION OF THE TEMPO CATHETER WAS CUT OFF, THE 8F VASCULAR SHEATH WAS REPLACED, THE KINKED TEMPO CATHETER WAS WITHDRAWN AND WAS REPLACED WITH A NEW TEMPO CATHETER. THE INTERVENTION WAS SUCCESSFULLY COMPLETED. THE PATIENT RETURNED TO THE WARD SAFELY. THERE WERE NO REPORTS OF PATIENT INJURY. THE PATIENT'S RIGHT SAPHENOUS VEIN AND FEMORAL VEIN THROMBOSIS HAD BEEN INEFFECTIVE WITH CONSERVATIVE MEDICAL TREATMENT AND THE PATIENT HAD UNDERGONE INFERIOR VENA CAVA FILTER PLACEMENT AND THROMBUS ASPIRATION. THE TEMPO CATHETER WAS INTRODUCED FOR IMAGING TO UNDERSTAND THE THROMBUS SITUATION, BUT THAT IS WHEN IT WAS DISCOVERED THAT THE CATHETER COULD NOT PASS SMOOTHLY. THE HOSPITAL REPORTED THIS CASE AS AN ADVERSE EVENT TO CHINA NMPA. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318395 ↗
• MalfunctionNov 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, WHEN THE 5F PIGTAIL 100CM 5-SIDEHOLE (SH) TEMPO DIAGNOSTIC CATHETER WAS TAKEN OUT OF THE PACKAGE, THE CATHETER SEPARATED INTO TWO PARTS. THERE WAS NO REPORTED PATIENT INJURY, AS THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS STORED CORRECTLY LIKE ALL THE PRODUCTS THAT ARE ALWAYS USED IN THIS HOSPITAL, WITH NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED WHERE ALL MEDICAL PRODUCTS ARE STORED, IN A WAREHOUSE WITH ACCESS CONTROL VIA PASSWORD. NO PHOTOS OF THE DEVICE WERE AVAILABLE AS THEY WERE DISCARDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684022 ↗
• MalfunctionOct 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A WHITE WAXY SUBSTANCE WAS FOUND IN THE TUBES OF TWO 5F 100 CM 5-SIDE HOLE (SH) TEMPO DIAGNOSTIC CATHETERS DURING PREP AND THE HARDNESS OF THE TUBE BODY WAS SIGNIFICANTLY INCREASED COMPARED WITH BEFORE. DUE TO THE ISSUE, A THIRD PIGTAIL ANGIOGRAPHIC TUBE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. THE DISCOVERY OF THIS ISSUE WAS MADE DURING A LOWER LIMB ARTERY INTERVENTIONAL SURGERY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING. A NON-CORDIS GUIDEWIRE WAS USED IN THE PATIENT, BUT THE CONTRAST CATHETER WITH WHITE WAX WAS NOT IMPLANTED IN THE PATIENT. THE PRODUCTS WERE DISCARDED AT SITE AND WILL NOT BE RETURNED. A PICTURE WAS RECEIVED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520634 ↗
• MalfunctionOct 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A WHITE WAXY SUBSTANCE WAS FOUND IN THE TUBES OF TWO 5F 100 CM 5-SIDE HOLE (SH) TEMPO DIAGNOSTIC CATHETERS DURING PREP AND THE HARDNESS OF THE TUBE BODY WAS SIGNIFICANTLY INCREASED COMPARED WITH BEFORE. DUE TO THE ISSUE, A THIRD PIGTAIL ANGIOGRAPHIC TUBE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. THE DISCOVERY OF THIS ISSUE WAS MADE DURING A LOWER LIMB ARTERY INTERVENTIONAL SURGERY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING. A NON-CORDIS GUIDEWIRE WAS USED IN THE PATIENT, BUT THE CONTRAST CATHETER WITH WHITE WAX WAS NOT IMPLANTED IN THE PATIENT. THE PRODUCTS WERE DISCARDED AT SITE AND WILL NOT BE RETURNED. A PICTURE WAS RECEIVED FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520584 ↗
• MalfunctionOct 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING THE ASSEMBLY OF A 5F 100CM 5 SIDEHOLE (SH) TEMPO PIGTAIL DIAGNOSTIC CATHETER, WHEN THE GUIDEWIRE ENTERED THE CATHETER, THE OPERATOR OBSERVED AN OBVIOUS WHITE WAXY SUBSTANCE, WHICH DISSOLVED AFTER FLUSHING WITH WATER AND WHICH WAS REMOVED WHEN INSERTING THE GUIDEWIRE. THE OPERATOR THEN SWITCHED TO ANOTHER GUIDEWIRE OF THE SAME MODEL, AND THE SAME CONDITION WAS OBSERVED. THE GUIDEWIRE USED WAS NON-CORDIS, AND THERE WAS A LITTLE RESISTANCE NOTED WHEN INSERTING THE GUIDEWIRE, BUT IT WAS NOT OBVIOUS. A THIRD GUIDEWIRE WAS THEN USED, AND IT WAS USED NORMALLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU, AND THERE WAS NO DAMAGE TO THE DEVICE OR PACKAGING PRIOR TO USE. THE STERILE POUCH WAS RECEIVED INTACT, AND THERE WAS NO OBVIOUS DAMAGE TO THE OUTER COATING OF THE CATHETER. THE TWO CONTRAST CATHETERS HAD BEEN DISCARDED BY THE OPERATOR AND COULD NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384857 ↗
• MalfunctionOct 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING THE ASSEMBLY OF A 5F 100CM 5 SIDEHOLE (SH) TEMPO PIGTAIL DIAGNOSTIC CATHETER, WHEN THE GUIDEWIRE ENTERED THE CATHETER, THE OPERATOR OBSERVED AN OBVIOUS WHITE WAXY SUBSTANCE, WHICH DISSOLVED AFTER FLUSHING WITH WATER AND WHICH WAS REMOVED WHEN INSERTING THE GUIDEWIRE. THE OPERATOR THEN SWITCHED TO ANOTHER GUIDEWIRE OF THE SAME MODEL, AND THE SAME CONDITION WAS OBSERVED. THE GUIDEWIRE USED WAS NON-CORDIS, AND THERE WAS A LITTLE RESISTANCE NOTED WHEN INSERTING THE GUIDEWIRE, BUT IT WAS NOT OBVIOUS. A THIRD GUIDEWIRE WAS THEN USED, AND IT WAS USED NORMALLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE IFU, AND THERE WAS NO DAMAGE TO THE DEVICE OR PACKAGING PRIOR TO USE. THE STERILE POUCH WAS RECEIVED INTACT, AND THERE WAS NO OBVIOUS DAMAGE TO THE OUTER COATING OF THE CATHETER. THE TWO CONTRAST CATHETERS HAD BEEN DISCARDED BY THE OPERATOR AND COULD NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384767 ↗
• MalfunctionSep 27, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WHEN A 5F 100 CM TEMPO PIGTAIL CATHETER WAS ASSEMBLED OUTSIDE THE PATIENT, A WHITE WAX-LIKE SUBSTANCE, MOVEABLE, SOLUBLE IN WATER, WAS FOUND AT THE TIP OF THE CATHETER THAT WAS BEING USED FOR PREOPERATIVE IMAGING OF VENA CAVA FILTER IMPLANTATION. THE CATHETER WAS DISCARDED AND A NEW TEMPO PIGTAIL CATHETER WAS USED FOR IMAGING. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER THE INSTRUCTIONS FOR USE (IFU) AT ROOM TEMPERATURE AWAY FROM LIGHT. NO ACTUAL PRODUCT DAMAGE WAS OBSERVED. THERE WAS NO DAMAGE TO THE SHIPPING BOX, OUTER PRODUCT BOX, OR INNER PRODUCT POUCH. THE STERILE POUCH RECEIVED WAS NOT OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. A PICTURE WAS PROVIDED FOR REVIEW. IN THE PHOTO, A CATHETER IS OBSERVED, AND ON THE DISTAL END OF THE CATHETER, A WHITE LIKE MATERIAL IS SEEN COMING OUT OF THE END. NO OTHER OUTSTANDING DETAILS OR ANOMALIES COULD BE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326916 ↗
• MalfunctionJul 2, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING PREOPERATIVE PREPARATION, A BROKEN HOLE WAS FOUND AT THE PROXIMAL END OF A 5F TEMPO PIGTAIL ANGIOGRAPHIC CATHETER AND SALINE SPRAYED OUT ABNORMALLY. THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661783 ↗
• MalfunctionMay 21, 2024Crack; Crack

  AS REPORTED, THE BODY SHAFT OF THE 5F 100 CM TEMPO PIGTAIL ANGIOGRAPHY CATHETER WAS FOUND "FRACTURED" BEFORE CLINICAL USE, WHEN THE PACKAGE WAS OPENED, AFFECTING ITS USE. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER TEMPO CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DEVICE DAMAGE NOTICED PRIOR TO OPENING THE PACKAGE OR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS NOT PREPPED AFTER THE DAMAGE WAS FOUND. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RE-STERILIZED. THE PRODUCT WILL NOT BE RETURNED. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363264 ↗
• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ACUTE CEREBRAL INFARCTION. THE PATIENT WAS SENT TO THE INTERVENTION ROOM FOR AORTIC ARCH + TOTAL CEREBRAL ANGIOGRAPHY AFTER ADMISSION. DURING THE PATIENT'S IMAGING PROCEDURE, THE DISTAL TIP OF TEMPO 5F 100CM PIG ANGIOGRAPHY CATHETER FRACTURED AND DISLODGED, RESULTING IN THE STUMP OF THE TUBE BEING LEFT IN THE PATIENT'S VESSEL. THE PIECE WAS IN STENOTIC SEGMENT OF THE COMMON CAROTID ARTERY. IT CAUSED INJURY TO THE PATIENT AND SERIOUSLY JEOPARDIZED THE PATIENT'S LIFE. THE SURGEON IMMEDIATELY PERFORMED ENDOVASCULAR CATHETER STUMP REMOVAL AFTER DISCOVERY. THE DISTAL TIP PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS IS KNOWN TO BE GOOD. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DAMAGE NOTED TO THE DEVICE NOTICED AFTER OPENING THE PACKAGE. THE DEVICE DID NOT PASS THROUGH ANY ACUTE BENDS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676656 ↗
• MalfunctionOct 27, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING PREP, A 5F 100CM PIGTAIL (PIG) 5 SIDE HOLES (SH) TEMPO CATHETER TIP WAS CONTAMINATED. THERE WERE DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THE PACKAGING DID NOT REMOVE. THERE WAS NO REPORTED PATIENT INJURY. ANOTHER TEMPO CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE CAROTID ARTERY WITH NO TORTUOSITY, CALCIFICATION, AND TWENTY PERCENT STENOSIS. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744626 ↗