TEMPO 451506P0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705032008358), received between Jul 6, 2021 and Dec 26, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Degraded” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, A MOVEABLE FOREIGN OBJECT WAS FOUND IN A 5F MULTIPURPOSE (MP) A1 (I) 125CM TEMPO DIAGNOSTIC CATHETER DURING FLUSHING WITH NORMAL SALINE PRIOR TO AN INTRACRANIAL THROMBECTOMY PROCEDURE. ANOTHER TEMPO DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE INVOLVED TREATMENT FOR AN ACUTE CEREBRAL INFARCTION. THE PRODUCT WAS STORED, HANDLED, AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DAMAGE WAS NOTED BEFORE OPENING THE PACKAGE. THERE WERE NO DIFFICULTIES REMOVING THE DEVICE FROM STERILE PACKAGING OR PREPARING IT, AND NO COMPONENT DAMAGE WAS IDENTIFIED PRIOR TO USE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE EVENT WAS REPORTED TO THE CHINA REGULATORY AUTHORITY AS A SERIOUS INJURY ADVERSE EVENT BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898716 ↗
• InjuryNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 5F TEMPO MULTIPURPOSE (MPA) 125CM DIAGNOSTIC CATHETER WAS "FRACTURED". THE FRACTURED CATHETER REMAINED OUTSIDE THE LONG SHEATH BUT DID NOT COMPLETELY DETACH FROM THE GUIDEWIRE TIP. THE OPERATOR SECURED THE GUIDEWIRE TIP WITH A GRASPING DEVICE, THEN RETRACTED THE FRACTURED CATHETER BACK INTO THE LONG SHEATH BEFORE REMOVING THE ENTIRE ASSEMBLY FROM THE BODY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE RADIOGRAPHIC IMAGE WAS SUBMITTED, AND IT SHOWS WHAT APPEARS TO BE A GUIDEWIRE, SHEATH THE DISTAL TIP OF A CATHETER AND THEY ARE SEEN TRAVERSING ANTERIOR TO THE VERTEBRAL COLUMN AND CURVING UPWARD TOWARD THE SKULL BASE. THE DISTAL TIP OF THE CATHETER SEPARATED FROM ITS PROXIMAL PORTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555188 ↗
• MalfunctionMay 23, 2025Degraded; Degraded

  AS REPORTED, SOME PARTICLES WERE FOUND INSIDE A 5F TEMPO 125 CM MULTI-PURPOSE A (MPA) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 4 TO 6 WEEKS PRIOR TO NOTIFYING THE REP VIA EMAIL. DURING WHICH TIME THE DEVICES HAD BEEN COLLECTED BUT REMAINED UNUSED. THE SPECIFIC PART OF THE DEVICE AFFECTED IS UNKNOWN, AS THE DEVICES WERE NEVER OPENED DUE TO VISIBLE PLASTIC PARTICLES OBSERVED THROUGH THE PACKAGING. THE ISSUE WAS FIRST NOTED WHEN THEY WERE ABOUT TO OPEN THE FIRST OF FIVE DEVICES IN THE BOX, AFTER THE PRODUCTS HAD BEEN RECEIVED AND STORED IN THE LAB USING NORMAL HANGERS. ALTHOUGH THE DEVICES WERE HANDLED APPROPRIATELY, THEY WERE NOT OPENED BECAUSE OF THE VISIBLE CONTAMINATION. THREE (3) IMAGES WERE RECEIVED SHOWING A CATHETER INSIDE A POUCH. BLUE POLYMER FLAKES ARE VISIBLE WITHIN THE PACKAGING, AND A PORTION OF THE STRAIN RELIEF APPEARS TO BE MISSING, SUGGESTING IT MAY BE THE SOURCE OF THE FLAKES. THE DEVICE (S) ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081467 ↗
• MalfunctionMay 23, 2025Degraded; Degraded

  AS REPORTED, SOME PARTICLES WERE FOUND INSIDE A 5F TEMPO 125 CM MULTI-PURPOSE A (MPA) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 4 TO 6 WEEKS PRIOR TO NOTIFYING THE REP VIA EMAIL. DURING WHICH TIME THE DEVICES HAD BEEN COLLECTED BUT REMAINED UNUSED. THE SPECIFIC PART OF THE DEVICE AFFECTED IS UNKNOWN, AS THE DEVICES WERE NEVER OPENED DUE TO VISIBLE PLASTIC PARTICLES OBSERVED THROUGH THE PACKAGING. THE ISSUE WAS FIRST NOTED WHEN THEY WERE ABOUT TO OPEN THE FIRST OF FIVE DEVICES IN THE BOX, AFTER THE PRODUCTS HAD BEEN RECEIVED AND STORED IN THE LAB USING NORMAL HANGERS. ALTHOUGH THE DEVICES WERE HANDLED APPROPRIATELY, THEY WERE NOT OPENED BECAUSE OF THE VISIBLE CONTAMINATION. THREE (3) IMAGES WERE RECEIVED SHOWING A CATHETER INSIDE A POUCH. BLUE POLYMER FLAKES ARE VISIBLE WITHIN THE PACKAGING, AND A PORTION OF THE STRAIN RELIEF APPEARS TO BE MISSING, SUGGESTING IT MAY BE THE SOURCE OF THE FLAKES. THE DEVICE (S) ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081455 ↗
• MalfunctionMay 23, 2025Degraded; Degraded

  AS REPORTED, SOME PARTICLES WERE FOUND INSIDE A 5F TEMPO 125 CM MULTI-PURPOSE A (MPA) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 4 TO 6 WEEKS PRIOR TO NOTIFYING THE REP VIA EMAIL. DURING WHICH TIME THE DEVICES HAD BEEN COLLECTED BUT REMAINED UNUSED. THE SPECIFIC PART OF THE DEVICE AFFECTED IS UNKNOWN, AS THE DEVICES WERE NEVER OPENED DUE TO VISIBLE PLASTIC PARTICLES OBSERVED THROUGH THE PACKAGING. THE ISSUE WAS FIRST NOTED WHEN THEY WERE ABOUT TO OPEN THE FIRST OF FIVE DEVICES IN THE BOX, AFTER THE PRODUCTS HAD BEEN RECEIVED AND STORED IN THE LAB USING NORMAL HANGERS. ALTHOUGH THE DEVICES WERE HANDLED APPROPRIATELY, THEY WERE NOT OPENED BECAUSE OF THE VISIBLE CONTAMINATION. THREE (3) IMAGES WERE RECEIVED SHOWING A CATHETER INSIDE A POUCH. BLUE POLYMER FLAKES ARE VISIBLE WITHIN THE PACKAGING, AND A PORTION OF THE STRAIN RELIEF APPEARS TO BE MISSING, SUGGESTING IT MAY BE THE SOURCE OF THE FLAKES. THE DEVICE (S) ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081164 ↗
• MalfunctionMay 23, 2025Degraded; Degraded

  AS REPORTED, SOME PARTICLES WERE FOUND INSIDE A 5F TEMPO 125 CM MULTI-PURPOSE A (MPA) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 4 TO 6 WEEKS PRIOR TO NOTIFYING THE REP VIA EMAIL. DURING WHICH TIME THE DEVICES HAD BEEN COLLECTED BUT REMAINED UNUSED. THE SPECIFIC PART OF THE DEVICE AFFECTED IS UNKNOWN, AS THE DEVICES WERE NEVER OPENED DUE TO VISIBLE PLASTIC PARTICLES OBSERVED THROUGH THE PACKAGING. THE ISSUE WAS FIRST NOTED WHEN THEY WERE ABOUT TO OPEN THE FIRST OF FIVE DEVICES IN THE BOX, AFTER THE PRODUCTS HAD BEEN RECEIVED AND STORED IN THE LAB USING NORMAL HANGERS. ALTHOUGH THE DEVICES WERE HANDLED APPROPRIATELY, THEY WERE NOT OPENED BECAUSE OF THE VISIBLE CONTAMINATION. THREE (3) IMAGES WERE RECEIVED SHOWING A CATHETER INSIDE A POUCH. BLUE POLYMER FLAKES ARE VISIBLE WITHIN THE PACKAGING, AND A PORTION OF THE STRAIN RELIEF APPEARS TO BE MISSING, SUGGESTING IT MAY BE THE SOURCE OF THE FLAKES. THE DEVICE (S) ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081104 ↗
• MalfunctionMay 23, 2025Degraded; Degraded

  AS REPORTED, SOME PARTICLES WERE FOUND INSIDE A 5F TEMPO 125 CM MULTI-PURPOSE A (MPA) CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 4 TO 6 WEEKS PRIOR TO NOTIFYING THE REP VIA EMAIL. DURING WHICH TIME THE DEVICES HAD BEEN COLLECTED BUT REMAINED UNUSED. THE SPECIFIC PART OF THE DEVICE AFFECTED IS UNKNOWN, AS THE DEVICES WERE NEVER OPENED DUE TO VISIBLE PLASTIC PARTICLES OBSERVED THROUGH THE PACKAGING. THE ISSUE WAS FIRST NOTED WHEN THEY WERE ABOUT TO OPEN THE FIRST OF FIVE DEVICES IN THE BOX, AFTER THE PRODUCTS HAD BEEN RECEIVED AND STORED IN THE LAB USING NORMAL HANGERS. ALTHOUGH THE DEVICES WERE HANDLED APPROPRIATELY, THEY WERE NOT OPENED BECAUSE OF THE VISIBLE CONTAMINATION. THREE (3) IMAGES WERE RECEIVED SHOWING A CATHETER INSIDE A POUCH. BLUE POLYMER FLAKES ARE VISIBLE WITHIN THE PACKAGING, AND A PORTION OF THE STRAIN RELIEF APPEARS TO BE MISSING, SUGGESTING IT MAY BE THE SOURCE OF THE FLAKES. THE DEVICE (S) ARE EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080817 ↗
• MalfunctionFeb 11, 2025Crack; Crack

  AS REPORTED, AFTER OPENING, THE 5F MP A1 TEMPO DIAGNOSTIC CATHETER WAS FOUND TO HAVE BROKEN OFF AT THE TIP. THE DEVICE DID NOT SEPARATE COMPLETELY. THIS CATHETER WAS DISCARDED AND REPLACED WITH AN IMAGING CATHETER. THE CASE WAS COMPLETED WITH CHANGING TO A NEW UNKNOWN CATHETER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING IN THE DEVICE. THE PRODUCT WAS STORED HANGING IN THE WAREHOUSE. THE DEVICE WAS NOT PREPPED AS THE ISSUE WAS FOUND WHEN OPENING THE PACKAGE. THE DEVICE WAS NOT USED IN THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358433 ↗
• InjuryDec 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 125CM TEMPO MULTIPURPOSE SMALL DIAGNOSTIC CATHETER BROKE NEAR THE TIP LOCATION DURING DELIVERY TO THE TARGET LOCATION. THE DEVICE SEPARATED IN TWO COMPLETELY SEPARATE PIECES. THE OPERATOR IMMEDIATELY PAUSED DELIVERY OF THE CATHETER AND TOOK MEASURES TO REMOVE THE CATHETER AND THE BROKEN SEGMENT. THE SEPARATED PIECE WAS REMOVED WITH AN UNKNOWN GUIDEWIRE AND CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A VERTEBRAL ARTERY STENOSIS SURGERY. THERE WAS NO ABNORMALITY OF THE CATHETER FOUND BEFORE UNPACKING AND BEFORE USE. THE CATHETER WAS DELIVERED WITH AN UNKNOWN GUIDEWIRE. THE DEVICE SEPARATED IN THE ABDOMINAL AORTA, WHICH HAD NORMAL VESSEL CHARACTERISTICS, NO CALCIFICATION, NO TORTUOSITY, NO STENOSIS, NO ACUTE ANGLE, AND NO BIFURCATION. THERE WAS NO RESISTANCE/FRICTION NOTED BETWEEN THE CATHETER AND GUIDE PRIOR TO THE SEPARATION. THERE WAS NO EXCESSIVE MANIPULATION/TORQUEING OF THE CATHETER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20911679 ↗
• InjuryNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING AN EMERGENCY THROMBOLYSIS PROCEDURE, THE DISTAL TIP OF A 5F 125CM MULTIPURPOSE (MPA) 1 TEMPO DIAGNOSTIC CATHETER SEPARATED INTO THE C1 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY DURING AN ANGIOGRAM PERFORMED WITH A SYRINGE. SEVERAL ATTEMPT TO REMOVE THE SEPARATED SEGMENT WERE MADE WITHOUT SUCCESS. AN UNKNOWN 200CM MICROFILAMENT WAS USED TO PASS THROUGH THE SEPARATED SEGMENT AND THE BALLOON WAS USED TO PULL OUT THE SEPARATED SEGMENT. AN UNKNOWN LONG SHEATH, UNKNOWN GUIDEWIRE, AND UNKNOWN SNARE WERE ALSO USED DURING REMOVAL OF THE SEPARATED SEGMENT. THIS EVENT DELAYED THE INTERVENTIONAL PROCEDURE, AND THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE FROM THE PATIENT. THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE HOSPITAL REPORTED THIS CASE AS A SERIOUS INJURY ADVERSE EVENT TO CHINA NMPA DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759697 ↗
• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE FIRST TIME THE 5F 125CM TEMPS MP A1 CONTRAST CATHETER WENT TOWARDS THE BLOOD VESSEL, AFTER REMOVING IT, THE OPERATOR WIPED THE BLOOD ON THE TUBE WITH GAUZE, AND THE TIP END OF THE TUBE BROKE OFF WITH A GENTLE RUBBING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE VESSEL HAD NO TORTUOSITY, AND THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION. DEVICE IMAGES SHOWING THE TIP BROKEN OFF ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279813 ↗
• MalfunctionAug 4, 2024Crack; Crack

  AS REPORTED, A 5F 125 CM MULTI-PURPOSE A, SMALL CURVE TEMPO ANGIOGRAPHIC CATHETER WAS REQUESTED FOR A PERIPHERAL PROCEDURE AND AT THE TIME OF PURGING IT WAS EVIDENT THAT THE CATHETER IS FRACTURED. THERE WAS NO REPORTED PATIENT INJURY. TWO (2) PICTURES WERE RECEIVED FOR REVIEW. A TEMPO CATHETER OF CATALOGUE 451-506P0 LOT 18137998 IS APPARENTLY INSIDE THE PACKAGING. NO ANOMALIES OR NOTABLE DETAILS WERE OBSERVED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902903 ↗
• MalfunctionDec 17, 2023Crack; Crack

  AS REPORTED, A 5F MULTIPURPOSE A1(L) 125CM TEMPO DIAGNOSTIC CATHETER WAS FOUND TO BE "BROKEN" IN SEVERAL PLACES OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED BY USING AN UNKNOWN "CONTRAST CATHETER". THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS INTENDED TO BE USED FOR A LOWER EXTREMITY ARTERIOPLASTY. THE ANGIOGRAPHY CATHETER WAS FOUND TO HAVE SEVERAL DAMAGES AFTER UNPACKING. THE ANOMALIES NOTED WERE NOTED BEFORE USE. THE DEVICE WAS INSPECTED PRIOR TO OPENING THE PACKAGE. THE DEVICE WAS INTENDED FOR USE IN A DIAGNOSTIC PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE WAS GOING TO BE FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342348 ↗
• MalfunctionJul 6, 2021Leak/Splash; Leak/Splash

  DURING PREP, IT WAS FOUND THAT THERE WAS AN AIR LEAKAGE AT THE INTERFACE OF A 5F 125CM TEMPO CATHETER. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW UNKNOWN PRODUCT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR A RENAL ARTERIOGRAPHY WHICH WAS MODERATELY TORTUOUS, CALCIFIED AND STENOSED. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO DAMAGED TO THE DEVICE PACKAGING. THE DEVICE WAS HANDLED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS FLUSHED WITH NO DIFFICULTIES DURING PREP. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE HOSPITAL HAS CHOSEN TO REPORT THIS AS AN ADVERSE EVENT TO THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) DIRECTLY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122454 ↗