TEMPO AQUA 452414H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032008843), received between Jan 30, 2019 and Mar 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJan 30, 2019Crack; Crack

  AS REPORTED, THE 4F TEMP AQUA (4FVER135 DEGREE 100CM) DIAGNOSTIC CATHETER WAS FOUND DAMAGED WHILE REMOVED IT FROM STERILE BAG. THE DAMAGE CONTAIN CRACK OF 1-CENTIMETERS (CM) NEAR THE HUB. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289440 ↗