TEMPO AQUA SRD6109Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032049795), received between Dec 27, 2024 and Jun 24, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, 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 THE KINKED CATHETER COULD NOT BE WITHDRAWN AT THAT TIME, AND ATTEMPTS WERE MADE TO ROTATE THE CATHETER IN BOTH DIRECTIONS WHILE TRYING TO WITHDRAW THE KINKED CATHETER BY UNTWISTING IT USING A GUIDEWIRE.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 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 ↗