TEMPO 451530H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032008563), received between Feb 5, 2019 and Mar 2, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Detachment of Device or Device Component

  AS REPORTED, A 5F SIMMONS (SIM) 1 100CM TEMPO DIAGNOSTIC CATHETER FRACTURED DURING USE, WITH A PORTION OF THE CATHETER BREAKING INSIDE THE BODY. THE BROKEN CATHETER WAS REMOVED USING A SNARE, CAUSING THE PROCEDURE TIME TO BE EXTENDED. THE DISTAL TIP OF THE DEVICE SEPARATED, AND NO ANOMALIES WERE NOTED WHEN IT WAS REMOVED FROM THE PACKAGE OR DURING PREPARATION. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE, NO EXCESSIVE TORQUEING WAS REQUIRED, AND NO RESISTANCE OCCURRED WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION, AND NO RESISTANCE WAS MET DURING WITHDRAWAL. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION, WAS NOT RESTERILIZED, AND THE PATIENT¿S CURRENT STATUS IS GOOD. THERE WERE NO OBVIOUS SIGNS OF DEVICE OR PACKAGING DAMAGE PRIOR TO USE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24489907 ↗
• MalfunctionJan 23, 2026Tear, Rip or Hole in Device Packaging

  AS REPORTED, THE PACKAGING FOR A 5F100CM SIDEWINDER SIMMONS 1 (SIM1) TEMPO DIAGNOSTIC CATHETER WAS FOUND DAMAGED UPON OPENING. AN IMAGE WAS PROVIDED WHICH DISPLAYS A TORN INNER PACKAGE. ANOTHER 5F100CM SIM1 TEMPO DIAGNOSTIC CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND OPENED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE WAS FOUND ON THE DEVICE ITSELF. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164346 ↗
• MalfunctionMay 20, 2024Leak/Splash; Leak/Splash

  AS REPORTED, DURING THE CEREBRAL ANGIOGRAPHY PROCEDURE FOR THE PATIENT, IT WAS FOUND THAT THE END OF THE 5F CORDIS SIM1 TEMPO CONTRAST CATHETER WAS BROKEN AND LEAKED WHEN IT WAS CONNECTED TO THE SYRINGE TO PUSH THE CONTRAST MEDIUM. THE DOCTOR CONNECTED TO THE SYRINGE, THEN CONTRAST MEDIA SPRAYED ALL OVER THE OPERATOR. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED AND NOT AVAILABLE FOR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352714 ↗
• MalfunctionFeb 5, 2019Crack; Leak/Splash; Material Puncture/Hole; Detachment of Device or Device Component; Crack; Leak/Splash; Material Puncture/Hole; Detachment of Device or Device Component

  AS REPORTED, THERE WERE CRACKS/PUNCTURES/CUTS IN THE 5F TEMPO ANGIOGRAPHIC CATHETER THREE POINTS FROM THE CENTER OF THE CATHETER UNTIL THE BEGINNING OF THE SIM SHAPE IN THE DISTAL PART OF THE CATHETER. THE CATHETER WAS BROKEN IN TWO OR MORE PIECES. THERE WAS A TOTAL BREAK IN THE END OF THE CATHETER AND TWO MORE BREAKS ALONG THE CATHETER. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS STORED IN THE CATH LAB HANGING OUT OF THE BOX FOR NO MORE THAN TWO MONTHS. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU, AND THE DEVICE DID NOT PREP NORMALLY. THE BREAKAGE WAS NOTED DURING PREP. THE ANOMALIES WERE NOTED WHILE FLUSHING THE 5F TEMPO ANGIOGRAPHIC CATHETER, SALINE SPILLED FROM ALL THE BREAKAGES. IN A MANUAL CHECKUP OF THE CATHETER, YOU CAN SEE THE TEXTURE OF THE CATHETER IS FRAGILE. THE CATHETER WAS NOT USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8307316 ↗