TEMPO 451503L5Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705032008280), received between Sep 11, 2020 and Feb 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Degraded

  AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472532 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511527 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, THE BODY OF A 5F TEMPO ANGIOGRAPHIC CATHETERS WAS PEELING OFF, APPEARING AS THOUGH IT WAS DECOMPOSING. THERE WAS NO REPORTED PATIENT INJURY. IT WAS FURTHER REPORTED THAT ADDITIONAL DEVICES FROM THE SAME LOTS AND SKUS EXHIBITED SIMILAR PEELING, WITH APPROXIMATELY NINETEEN DEVICES AFFECTED. IT WAS CONFIRMED THAT THE REMAINING DEVICES WERE STERILE AND EXHIBITED THE SAME FAILURE. DEVICES ARE STORED IN THE WAREHOUSE ALONG WITH OTHER MEDICAL DEVICES. OZONE IS NOT USED TO DISINFECT, AND IT IS NOT USED IN ANY AREAS SUCH AS PROCEDURE OR STORAGE ROOMS. FOUR IMAGES WERE PROVIDED, SHOWING BLUE FLAKES ON A BLOOD-SOAKED SURGICAL TOWEL, CRACKS ON THE CATHETER BODY AND STRAIN RELIEF, AND YELLOWISH DISCOLORATION TO THE HUB. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511439 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511214 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511042 ↗
• MalfunctionOct 28, 2024Degraded; Degraded

  AS REPORTED, UPON OPENING THE BOX, THE 5F PIGTAILED 110CM 5 SIDE HOLE (SH) TEMPO DIAGNOSTIC CATHETER ARRIVED WITH PARTICLES INSIDE THE PACKAGE. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. ALL DEVICES ARE STORED IN THE SAME LOCATION, WHICH IS NOT A STORAGE ISSUE, AND THEY RECEIVE THE SAME EXPOSURE TO LIGHT. THE DEVICES ARE KEPT IN THEIR WHITE OUTER BOXES UNTIL THEY ARE USED. THEY ARE STORED IN CABINETS, BUT IT IS NOT SPECIFIED WHETHER THESE CABINETS HAVE TRANSPARENT DOORS OR ARE DARK. THE SHIPMENT OF DEVICES IS STORED IN AN ENVIRONMENT THAT IS NOT CLIMATE CONTROLLED BEFORE BEING STORED IN THE LAB, BUT THIS IS NOT CONSIDERED A STORAGE ISSUE. PRODUCTS ARE ALWAYS STORED PROPERLY, AND THE HOSPITAL AIR CONDITIONING IS JUST A STORAGE AREA. THE DEVICE HAS NOT BEEN REPROCESSED OR RE-STERILIZED AS IT REMAINS IN ITS ORIGINAL PACKAGING AND HAS NOT BEEN USED. THE DEVICE IS NOT EXPOSED TO UV LIGHTING OR ANY FORM OF STERILIZATION PROCESS AT ANY POINT, AND THE LAB DOES NOT USE ANY UV OR STERILIZATION PROCESS IN GENERAL. OTHER DEVICES IN THE BOX WERE EXAMINED, AND THEY DID NOT HAVE THE SAME MALFUNCTION. THE DEVICE WILL BE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552104 ↗
• MalfunctionSep 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 110CM 5 SIDE HOLES (SH) PIGTAIL TEMPO CATHETER WAS FOUND BROKEN INTO TO TWO PIECES, WHEN THEY OPENED IT. IT WAS ALSO NOTED THAT THE DEVICE WAS OPENED BEYOND THE EXPIRATION DATE BUT IT WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10520705 ↗