TEMPO 451504V5Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705032008327), received between Jan 31, 2018 and Apr 4, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2026Detachment of Device or Device Component

  AS REPORTED, THE DISTAL END OF THE 5F UF 65CM TEMPO CATHETER BECAME BENT AND DETACHED WHILE ON THE WIRE. THE WIRE, CATHETER AND BROKEN PORTION WAS PULLED OUT OF THE SHEATH WITH NO HARM TO THE PATIENT. THE BREAK OCCURRED WHILE ATTEMPTING TO ADVANCE THE CATHETER UP AND OVER THE ILIAC BIFURCATION. NO UNUSUAL FORCE WAS APPLIED, ALTHOUGH THE ILIAC VESSELS WERE NOTED TO BE TORTUOUS. THE INTENDED PROCEDURE WAS A LEG ANGIOGRAM FOR DISTAL DISEASE. THE LESION HAD LITTLE OR NO CALCIFICATION, AND VESSEL TORTUOSITY WAS PRESENT. THE DEVICE WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DEVICES ARE STORED HANGING ON A CATHETER SUPPLY CART AND ARE SOMETIMES KEPT IN PROCEDURE OR SUPPLY AREAS DURING ROOM TURNOVER, WITHOUT EXPOSURE TO OUTDOOR LIGHT OR ADVANCED DECONTAMINATION METHODS SUCH AS UV-C, VHP, OZONE, OR FOGGING. DEVICES ARE REMOVED FROM THE OUTER BOX AND STORED ON HANGERS WITH OTHER CATHETERS, NOT IN CABINETS. STORAGE ENVIRONMENTS ARE CLIMATE CONTROLLED WITH NO KNOWN FACILITY ISSUES (E.G., HVAC, HUMIDITY, LEAKS) OR RECENT CHANGES TO CLEANING OR STORAGE PRACTICES. THE DEVICE IS NOT REPROCESSED OR EXPOSED TO UV OR STERILIZATION PROCESSES. A NON-CORDIS GUIDEWIRE WAS USED. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784463 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478971 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478920 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475704 ↗
• MalfunctionApr 4, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, A 5F TEMPO UNIVERSAL FLUSH 65 CM DIAGNOSTIC CATHETER PIERCED THE NON-CORDIS GUIDE CATHETER DURING ITS ASCENT TO PERFORM THE CROSSOVER. THE GUIDE AND THE DEVICE WERE REMOVED SIMULTANEOUSLY AND THE CATHETER HAD TO BE CUT INTO 3 PIECES TO BE ABLE TO REMOVE IT. THERE WAS NO REPORTED PATIENT INJURY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048073 ↗
• InjuryNov 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 65CM 5SH UNIVERSAL FLUSH (UF) TEMPO CATHETER STUCK ONTO AN UNKNOWN WIRE AND THEN BROKE AS THE PHYSICIAN PULLED ON THE CATHETER. AS IT WAS PULLED, THE CATHETER WAS STRETCHED AND BROKE. APPROXIMATELY 1 INCH OF THE TIP OF THE CATHETER, THAT BROKE, WAS LEFT IN THE PATIENT. AT THAT TIME, THE PHYSICIAN WAS ABLE TO SNARE OUT THE BROKEN PIECE. THE RETRIEVAL OF THE BROKEN CATHETER FROM THE PATIENT'S BODY WAS CONFIRMED UNDER FLUOROSCOPY AND CONTRAST PICTURES. THE PATIENT WENT TO RECOVERY AND HAD NO ISSUES AFTER THE PROCEDURE. THE COMPLAINT DEVICE WAS USED IN A DIAGNOSTIC PROCEDURE AND WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN WAS TRAINED IN THE USE OF THIS DEVICE. THERE WAS NO VESSEL TORTUOSITY. THERE WAS NORMAL VESSEL ANGULATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT RE-STERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE AND NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15757332 ↗
• InjuryDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER USING A 5F UF TEMPO CATH FOR AN ANGIOGRAM/RUNOFF OF THE LOWER EXTREMITIES, THE DISTAL TIP OF THE CATHETER BROKE OFF IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR VASCULAR SURGERY AFTER THE ATTEMPT TO SNARE THE TIP WAS UNSUCCESSFUL. THERE WERE NO ANOMALIES NOTED TO THE DEVICE WHEN REMOVED FROM THE PACKAGE AND NO ANOMALIES NOTED DURING THE PREP OF THE CATHETER. THE DEVICE WAS INSERTED INTO THE HEMOSTATIC VALVE. THERE WAS NO RESISTANCE WHILE ADVANCING THE CATHETER THROUGH THE VESSEL AND EXCESSIVE TORQUEING WAS NOT REQUIRED. THERE WAS RESISTANCE/FRICTION NOTED AS THE CATHETER WAS ADVANCED OVER THE .035 NON-CORDIS WIRE. RESISTANCE WAS FELT WHILE ATTEMPTING TO WITHDRAWAL THE CATHETER FROM THE PATIENT; HOWEVER, EXCESSIVE FORCE WAS NOT NEEDED DURING THE REMOVAL. THE LESION WAS IN THE EXTERNAL ILIAC ARTERY (EIA) AND WAS NOTED TO HAVE SEVERE CALCIFICATION. THE TWO PIECES WERE REMOVED BY USING A SNARE. THE CASE WAS NOT COMPLETED DUE TOT THE DISTAL TIP OF THE UF CATHETER SEPARATING IN THE EIA/CFA. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965763 ↗
• MalfunctionSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PHYSICIAN TOOK THE UNIVERSAL FLUSH UP AND OVER AND INTO THE ILIAC WHERE HE PULLED BACK THE UNKNOWN WIRE AND NOTED THAT THE CATHETER OF A 5F 65CM 5 SIDE HOLES (5SH) TEMPO DIAGNOSTIC CATHETER SPRUNG BACK TO ITS ORIGINAL SHAPE AND DISSECTED THE ARTERY. THE PATIENT REQUIRED A STENT TO BE PLACED INTO THE ARTERY FOR THE DISSECTION. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE DEVICE WAS STORED IN THE PROCEDURE ROOM FOR UNDER 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 IT WAS 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 RESISTANCE/FRICTION. THERE WAS NO UNUSUAL FORCE USED AT ANYTIME. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED.

  Patient problems: Vascular Dissection

  MAUDE report 10528424 ↗
• MalfunctionJan 31, 2018Crack; Crack

  IT WAS REPORTED THAT THERE WAS A DEFECT NEAR THE PIGTAIL END OF THE TEMPO 5F UF 65CM 5SH CATHETER AS THE END STARTED TO BREAK OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230532 ↗
• MalfunctionJan 31, 2018Crack; Crack

  IT WAS REPORTED THAT THERE WAS A DEFECT NEAR TWO OF THE PIGTAIL END OF THE TEMPO 5F UF 65CM 5SH CATHETER AS THE END STARTED TO BREAK OFF. SIX OTHER DEVICES WERE ALSO RETURNED THAT WERE DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230530 ↗