TEMPO AQUA 452514H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032008997), received between Oct 20, 2020 and Oct 20, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TWO (2) 4F 65CM 5 SIDE HOLES (SH) UNIVERSAL FLUSH (UF) TEMPO CATHETERS WERE SHEARED OFF JUST BELOW THE LAST FLUSH HOLES WHERE IT ATTACHED TO THE ACTUAL SHAFT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS USED IN THE NORMAL MANNER. THE DEVICES WERE STORED IN THE CATH LAB FOR LESS THAN A MONTH. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO EXCESS FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS. THERE IS NO PROCEDURAL CD/ANGIOGRAM/ DEVICE IMAGES AVAILABLE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705498 ↗
• MalfunctionOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TWO (2) 4F 65CM 5 SIDE HOLES (SH) UNIVERSAL FLUSH (UF) TEMPO CATHETERS WERE SHEARED OFF JUST BELOW THE LAST FLUSH HOLES WHERE IT ATTACHED TO THE ACTUAL SHAFT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS USED IN THE NORMAL MANNER. THE DEVICES WERE STORED IN THE CATH LAB FOR LESS THAN A MONTH. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICES. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THERE WAS NO DAMAGE NOTICED TO THE DEVICES PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICES FROM THE STERILE PACKAGING. THERE WAS NO EXCESS FORCE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS. THERE IS NO PROCEDURAL CD/ANGIOGRAM/ DEVICE IMAGES AVAILABLE. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705418 ↗