TEMPO 451404V5Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705032007733), received between Mar 3, 2020 and Mar 2, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Detachment of Device or Device Component

  AS REPORTED, A 4F 65CM UF TEMPO CATHETER USED IN LEG ANGIOGRAM CASE. THE CATHETER SNAPPED ABOUT 2 INCHES FROM THE TIP DURING REMOVAL FROM THE SHEATH. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CATHETER OF THE SAME PRODUCT CODE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO APPARENT DAMAGE NOTED PRIOR TO USE. THERE WAS NO RESISTANCE OR FRICTION WHILE ADVANCING THROUGH THE VESSEL, AND NO UNUSUAL FORCE WAS REQUIRED DURING ADVANCEMENT OR WITHDRAWAL OF THE CATHETER. THE INTENDED PROCEDURE WAS A DIAGNOSTIC LEG ANGIOGRAM, WITH NO LESION PRESENT. THE VESSEL SHOWED NO CALCIFICATION OR TORTUOSITY, AND THERE WAS NO RESISTANCE WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483062 ↗
• InjuryOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F UF 65CM TEMPO DIAGNOSTIC CATHETER BROKE OFF IN THE COMMON ILIAC ARTERY DURING CROSS-OVER WITHDRAWAL WITH MINIMAL VESSEL CALCIFICATION. NO PRESSURE WAS APPLIED. THE CATHETER DID NOT BECOME ENTRAPPED. THE SEPARATED WIRE TIP WAS SUCCESSFULLY EXTRACTED THROUGH A SHEATH WITH A SCREW-OFF VALVE. THE INTENDED PROCEDURE WAS A CROSS-OVER INTERVENTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). NO ADDITIONAL TEMPO CATHETER WAS USED, AND A CONTRALATERAL APPROACH WAS NOT EMPLOYED. THE DISTAL TIP OF THE DEVICE SEPARATED DURING THE PROCEDURE. THE TIP WAS LOST IN THE ILIAC ARTERIES DURING USE FOR THE CROSS-OVER PROCEDURE AND WAS LOCATED AT THE ILIAC BIFURCATION. THE ILIAC ARTERIES SHOWED NO CALCIFICATION, TORTUOSITY, STENOSIS, ACUTE ANGLE, OR BIFURCATION ISSUES. AT THE ACCESS SITE, MILD CALCIFICATION WAS NOTED WITH NO TORTUOSITY, STENOSIS, ACUTE ANGLE, OR BIFURCATION. THE DEVICE WAS NOT PULLED OR TORQUED BY THE HUB. NO DIFFICULTIES WERE ENCOUNTERED DURING INSERTION OR ADVANCEMENT OF THE DEVICE, BUT DIFFICULTY WAS REPORTED DURING WITHDRAWAL. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE IFU, WITH NO DAMAGE NOTED PRIOR TO OPENING THE PACKAGE AND NO DIFFICULTY REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318521 ↗
• MalfunctionJan 31, 2022Fracture; Fracture

  DURING USE IN THE PATIENT OF THE TEMPO DIAGNOSTIC UNIVERSAL FLUSH (UF) CATHETER, THE CATHETER ALMOST SEPARATED AND THE WIRE CAME OUT THE SIDE. THERE WAS NO PATIENT INJURY. ANOTHER TEMPO CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE TARGET LESION IS THE ILIAC BIFURCATION WHICH IS MILDLY TORTUOUS AND CALCIFIED. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO RESISTANCE WITH ADVANCING OR WITHDRAWING THE CATHETER. THERE WERE NO EXCESSIVE FORCE USED ANYTIME DURING THE PROCEDURE. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404316 ↗
• InjuryAug 16, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AFTER MUCH TRIAL, THE 4F UNIVERSAL FLUSH (UF) 65CM 5 SIDE HOLES (SH) TEMPO DIAGNOSTIC CATHETER ONLY ADVANCED HALF-WAY AROUND ILIAC BIFURCATION AND GOT STUCK. AFTER MUCH MANIPULATION, THE CATHETER WAS WITHDRAWN WITH MUCH DIFFICULTY AND ABOUT 3CM OF THE DISTAL TIP SEPARATED AND WAS STUCK AT THE BIFURCATION OF THE ILIAC ARTERIES. THE CLINICIAN REMOVED THE PIECE OF CATHETER USING AN UNKNOWN GUIDEWIRE, A NON-CORDIS 45CM DESTINATION SHEATH AND A SLEEK BALLOON 3.5X20 TO FREE-UP THE STUCK CATHETER PIECE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE TEMPO CATHETER WAS ADVANCED OVER AN AQUATRACK GUIDEWIRE THRU A 4F AVANTI SHEATH IN THE LEFT GROIN FEMORAL ARTERY. THE CATHETER WAS ATTEMPTED TO BE PASSED OVER THE ILIAC BIFURCATION TO THE CONTRALATERAL SIDE OVER THE AQUATRACK WIRE. THERE WERE HEAVY CALCIFICATION AND STENOSIS IN THE COMMON ILIAC ARTERIES, THE CLINICIAN HAD MUCH DIFFICULTY GETTING THE CATHETER TO ADVANCE OVER THE BIFURCATION. THERE WAS MODERATE VESSEL TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323524 ↗
• InjuryMay 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PERIPHERAL ANGIOGRAM, THE DISTAL END OF A 4F 5 SIDE HOLES (5SH) 65CM UNIVERSAL FLUSH TEMPO DIAGNOSTIC CATHETER BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DEVICE. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828578 ↗
• MalfunctionSep 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, PRIOR TO INSERTION OF 4F UNIVERSAL FLUSH (UF) 65CM 5 SIDE HOLES (SH) TEMPO DIAGNOSTIC CATHETER THROUGH THE UNKNOWN SHEATH AND INTO THE PATIENT, THE TEMPO CATHETER WAS BEING PASSED OVER THE UNKNOWN WIRE, HOWEVER, THE TIP OF THE CATHETER SEPARATED FROM THE SHAFT. DEVICE WAS PROMPTLY REMOVED SO THAT THE END DID NOT GET LOST INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN WAS CARRYING OUT A BILATERAL ILIAC IN THE HYBRID THEATRE. BOTH COMMON FEMORAL ARTERIES WERE PUNCTURED AND HAD 7FR SHEATHS INSERTED. THE CATHETER WAS FLUSHED BY THE SCRUB NURSE AND HANDED TO THE PHYSICIAN PRIOR TO DOING A RUN TO VISUALISE THE ILIAC'S USING THE INJECTOR PUMP. THE PHYSICIAN THEN PUT THE CATHETER OVER A 180CM J STARTER WIRE, WHICH ADVANCED HALF WAY UP THE WIRE. WHILST ADVANCING THE CATHETER OVER THE WIRE, THE TIP OF THE CATHETER (THE CURVED SECTION OF THE CATHETER) CAME APART FROM THE STRAIGHT SHAFT OF THE CATHETER, PRIOR TO INSERTION OF THE SHEATH. IT DID NOT GO IN THE PATIENT. THE TIP OF THE CATHETER AND THE REST OF THE CATHETER WERE TAKEN OFF AND PUT TO THE SIDE FOR INVESTIGATION. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511213 ↗
• MalfunctionAug 28, 2020Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THE TEMPO 4F UF 65CM 5SH CATHETER WAS TAKEN UP TO THE ILIAC ARCH. THE AQUATRACK APPEARED TO EXIT THROUGH THE SIDE HOLE OF THE TEMPO 4F UF 65CM 5SH AND NOT THE END HOLE. THEREFORE, THE TEMPO ANGIOGRAPHIC CATHETER WAS REPLACED WITH ANOTHER UNKNOWN UF CATHETER AND THE PROCEDURE WAS COMPLETED. THE CATHETER WAS STORED ON A SHELF WITH THE OTHER CATHETERS FOR APPROXIMATELY ONE MONTH. THE DEVICE WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN THEY WERE TAKEN OUT OF THE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THE CATHETER DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THERE WAS UNUSUAL FORCE USED DURING THE PROCEDURE. THE TARGET LESION WAS THE ILIAC WITH MODERATE CALCIFICATION. THERE WAS MODERATE VESSEL TORTUOSITY. THERE WAS SEVENTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10468378 ↗
• MalfunctionMar 3, 2020Crack; Crack

  DURING AN ANGIOPLASTY, A 4F 65CM TEMPO UNIVERSAL FLUSH (UF) WITH 5 SIDE HOLES (SH) WAS INSERTED NORMALLY THROUGH A SHEATH BUT WHILE FLUSHING, THE PHYSICIAN DID NOT SEE THE CONTRAST PROPERLY. WHEN HE WITHDREW THE CATHETER, HE NOTICED THAT IT WAS DAMAGED AND OUT OF ORDER. THE DAMAGE WAS NOTED AFTER WITHDRAWING THE CATHETER, IT WAS COMPRESSED/CRUSHED AND WAS TORN. THE CATHETERS WERE NOT INTACT BUT WAS REMOVED IN ONE PIECE, AS THERE WERE NO FRAGMENTS LEFT INSIDE THE BODY. IT HAPPENED WITH 2 CATHETERS WITH THE SAME LOT NUMBER. THE DEVICE WAS STORED AND HANDLED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCTS FROM THE PACKAGING. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT RE-STERILIZED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WERE NO DIFFICULTY OR RESISTANCE DURING PREP. THERE WERE NO DIFFICULTY OR RESISTANCE DURING INSERTION OF DILATOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783097 ↗
• MalfunctionMar 3, 2020Crack; Crack

  DURING AN ANGIOPLASTY, A 4F 65CM TEMPO UNIVERSAL FLUSH (UF) WITH 5 SIDE HOLES (SH) WAS INSERTED NORMALLY THROUGH A SHEATH BUT WHILE FLUSHING, THE PHYSICIAN DID NOT SEE THE CONTRAST PROPERLY. WHEN HE WITHDREW THE CATHETER, HE NOTICED THAT IT WAS DAMAGED AND OUT OF ORDER. THE DAMAGE WAS NOTED AFTER WITHDRAWING THE CATHETER, IT WAS COMPRESSED/CRUSHED AND WAS TORN. THE CATHETERS WERE REMOVED INTACT BUT IN ONE PIECE (I.E. NO FRAGMENTS LEFT INSIDE THE BODY). IT HAPPENED WITH 2 CATHETERS WITH THE SAME LOT NUMBER. THE DEVICE WAS STORED AND HANDLED AS PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCTS FROM THE PACKAGING. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THERE WAS NO DIFFICULTY IN REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS NOT RE-STERILIZED. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WERE NO DIFFICULTY OR RESISTANCE DURING PREP. THERE WERE NO DIFFICULTY OR RESISTANCE DURING INSERTION OF DILATOR. THERE WERE NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783064 ↗