TEMPO 451513H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705032008440), received between Mar 4, 2023 and Nov 10, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Degraded” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510031 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509952 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509896 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509883 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509872 ↗
• MalfunctionNov 10, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509670 ↗
• MalfunctionNov 9, 2025Degraded; Degraded

  AS REPORTED, BLUE PLASTIC PIECES WERE FOUND BROKEN OFF INSIDE THE PACKAGES OF SEVEN 5F TEMPO DIAGNOSTIC CATHETERS THAT WERE HANGING FROM A CART. THERE WAS NO REPORTED PATIENT INJURY. ONE PACKAGE OF 5F 100CM TEMPO DIAGNOSTIC CATHETERS SHOWED VISIBLE DAMAGE, AND ALL SEVEN DEVICES FROM THE SAME LOT ARE BEING RETURNED. THE DEVICES REMAIN INTACT IN THEIR ORIGINAL STERILE PACKAGING AND HAVE NOT BEEN OPENED. THE DEVICES WERE STORED IN A STERILE OPERATING ROOM UNDER STANDARD HOSPITAL LIGHTING AND KEPT WITHIN THE CATHETER CABINET INSIDE THE PROCEDURE ROOM WITH GLASS PANEL DOORS. ALL STORAGE AREAS ARE CLIMATE CONTROLLED, AND THE DEVICES WERE NOT REPROCESSED, RESTERILIZED, OR EXPOSED TO UV OR OZONE DISINFECTION. THE HOSPITAL DID NOT OBSERVE THE SAME MALFUNCTION IN OTHER UNITS BUT CHOSE TO RETURN THE ENTIRE LOT AS A PRECAUTION TO ENSURE PATIENT SAFETY. ALL SEVEN DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23507506 ↗
• MalfunctionJan 8, 2024Crack; Crack

  AS REPORTED, A 5F TEMPO BERENSTEIN (BER) 100CM DIAGNOSTIC CATHETER RIPPED AT ITS MIDPOINT FROM THE TIP AFTER INSERTION INTO THE LEFT FEMORAL ARTERY. THE CATHETER WAS SAFELY REMOVED FROM THE PATIENT¿S BODY. THIS INFORMATION IS SOURCED FROM MEDWATCH MW5147733. ADDITIONAL EVENT DETAILS ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465584 ↗
• MalfunctionNov 6, 2023Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE SIDE OF A 5F TEMPO BERENSTEIN (BER) 0.038IN X 100CM DIAGNOSTIC CATHETER RIPPED AND TWISTED WHILE IN THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073561 ↗
• MalfunctionMar 4, 2023Crack; Crack

  AS REPORTED, UPON OPENING, THE BODY OF 5F 100CM BERNSTEIN TEMPO ANGIOGRAPHIC CATHETER REVEALED A FRACTURE OF THE BODY, WHICH IS WHY IT WAS NOT USED IN THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY. IMAGE REVIEW DEMONSTRATES THAT NO FRACTURE CONDITION WAS FOUND ON THE DEVICE, HOWEVER THE CATHETER DOES APPEAR TO HAVE A KINKED CONDITION LOCATED ON THE SHAFT OF THE CATHETER. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483475 ↗