TEMPO 451443V2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032008075), received between Jun 15, 2019 and Apr 15, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICES WERE NOT RETURNED FOR EVALUATION. A PICTURE PROVIDED FOR REVIEW CONFIRMED FLAKING OF THE STRAIN RELIEF AS OBSERVED INSIDE THE 3 SEALED BAGS SHOWN IN THE PICTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105231 ↗
• MalfunctionMar 28, 2024Degraded; Flaked; Detachment of Device or Device Component; Degraded; Flaked; Detachment of Device or Device Component

  AS REPORTED, THERE WERE BLUE FLAKES FOUND WITHIN THE PACKAGING OF A 6F MULTI-PURPOSE (MP) A2 100CM 2 SIDE-HOLE (SH) SUPER TORQUE ANGIOGRAPHIC CATHETER. THE USER PUT IT TO THE SIDE TO GIVE TO SUPPLY AND PROCEEDED TO GET ANOTHER CATHETER OF THE SAME SIZE AND CURVE. HE INSPECTED THE PACKAGING AND NOTICED NO DEFECTS. HE HANDLED OFF THE CATHETER TO A STERILE TECHNICIAN. DURING THE CARDIAC CATHETERIZATION PROCEDURE UNDER X-RAY, THE PROVIDER FELT SOMETHING ON HIS HANDS. HE LOOKED DOWN AT HIS HANDS AND NOTICED BLUE PLASTIC FLAKES ON HIS STERILE GLOVES. WHEN THE LIGHTS CAME ON (AS THEY TURN OFF WHEN USING X-RAYS) THERE WAS BLUE PLASTIC FLAKES ON THE STERILE FIELD. THERE WERE NO REPORTS OF PATIENT INJURY. THE PROVIDER CHANGED OUT HIS STERILE GLOVES AND PROCEEDED TO REMOVE THE CATHETER THAT WAS IN THE RIGHT HEART ATRIUM. HE DID THIS AS PRECAUTION SINCE THE BLUE FLAKES WERE THE SAME COLOR OF THE CATHETER THAT WAS REMOVED. THE STERILE TEAM INSPECTED THE FIELD AND REMOVED ANY PARTICLES FROM THE FIELD. THE ENTIRE ITEM LOT WAS REMOVED FROM INVENTORY. AT THE TWO WEEKS POST-OP APPOINTMENT, THE PATIENT COMPLAINED OF A BRIEF 1-HOUR BLURRINESS SINCE THE PROCEDURE. SHE DID NOT SEEK OUT ANY MEDICAL CARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990301 ↗
• MalfunctionSep 29, 2023Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, THERE WAS PRESENCE OF A HOLE IN THE CATHETER WALL IN THE DISTAL END OF A 4F 65CM TEMPO CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843087 ↗
• InjuryAug 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO TEMPO CATHETERS (CATH TEMPO 4F C2 65CM 2SH) BECAME SEPARATED WHILE BEING USED WITH A NON-CORDIS LIVER AND BIOPSY SET. THE SEPARATED SEGMENTS MIGRATED TO THE LUNG ARTERIES AND WERE SNARED/RETRIEVED USING TWO UNKNOWN DEVICE. THE DEVICES WERE CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THREE DIFFERENT CORDIS PACKAGES WERE RETURNED WITH ONLY TWO CORDIS CATHETERS (CATH TEMPO 4F C2 65CM 2SH). THE CUSTOMER REPORTS ONLY TWO CATHETER TIPS BROKE, ONE WAS INTACT AND USED AFTERWARDS. THE DEVICE KINKED IN THE AREA OF SEPARATION. THE DEVICE SEPARATED APPROXIMATELY 2.5CM AND 2.3CM FROM THE DISTAL END. THERE WERE NO ANOMALIES NOTED WHEN REMOVING THE DEVICES FROM THE PACKAGING. THERE WERE NO ANOMALIES NOTED DURING PREP. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THERE WAS NO EXCESSIVE TORQUING REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8869664 ↗
• InjuryJun 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, TWO TEMPO CATHETERS (CATH TEMPO 4F BER II 65CM, CATH TEMPO 4F MP A1 (I) 65CM, CATH TEMPO 4F BER II 65CM) BECAME SEPARATED WHILE BEING USED WITH A NON-CORDIS LIVER AND BIOPSY SET. THE SEPARATED SEGMENTS MIGRATED TO THE LUNG ARTERIES AND WERE SNARED/RETRIEVED USING AN UNKNOWN DEVICE. THE DEVICES WERE CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS. THREE DIFFERENT CORDIS PACKAGES WERE RETURNED WITH ONLY TWO CORDIS CATHETERS. IT IS UNKNOWN WHICH LOT CORRESPONDS WITH WHICH CATHETER. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE SEPARATED APPROXIMATELY 2.5CM AND 2.3CM FROM THE DISTAL END.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8702378 ↗