TEMPO 451403F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032007689), received between Jun 19, 2025 and Jun 20, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, WHEN INSERTING A 4F 90 CM TEMPO PIGTAIL (PIG) CATHETER INTO AN UNKNOWN SHEATH, THE PART ATTACHED TO THE HUB CAME LOOSE AND WAS BROKEN. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. ONLY ONE DEVICE WAS USED IN THE PATIENT. THIS DEVICE DID NOT HAVE ANY PARTICLES NOTED. ALL THE ONES FROM THE SAME BATCH WERE COLLECTED, AND BASED ON THE ADDITIONAL INFORMATION RECEIVED, TWO (2) STERILE DEVICES HAD PARTICLES INSIDE THE SEALED PACKAGING AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE INVOLVED THE LEGS. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. THE DAMAGE OBSERVED WAS DESCRIBED AS "FRAYED, SPLIT, OR TORN" AND WAS NOTICED DURING USE IN THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, WHICH WAS PREPPED PER THE IFU WITHOUT ANY ISSUES. ANOTHER TEMPO CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE, SINCE TWO WERE FOUND TO CONTAIN PARTICLES INSIDE THE PACKAGING UPON INSPECTION; ONE OF THEM WAS SAVED, AND THE OTHER ONE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296524 ↗
• MalfunctionJun 20, 2025Degraded; Degraded

  AS REPORTED, WHEN INSERTING A 4F 90 CM TEMPO PIGTAIL (PIG) CATHETER INTO AN UNKNOWN SHEATH, THE PART ATTACHED TO THE HUB CAME LOOSE AND WAS BROKEN. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. ONLY ONE DEVICE WAS USED IN THE PATIENT. THIS DEVICE DID NOT HAVE ANY PARTICLES NOTED. ALL THE ONES FROM THE SAME BATCH WERE COLLECTED, AND BASED ON THE ADDITIONAL INFORMATION RECEIVED, TWO (2) STERILE DEVICES HAD PARTICLES INSIDE THE SEALED PACKAGING AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE INVOLVED THE LEGS. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. THE DAMAGE OBSERVED WAS DESCRIBED AS "FRAYED, SPLIT, OR TORN" AND WAS NOTICED DURING USE IN THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, WHICH WAS PREPPED PER THE IFU WITHOUT ANY ISSUES. ANOTHER TEMPO CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE, SINCE TWO WERE FOUND TO CONTAIN PARTICLES INSIDE THE PACKAGING UPON INSPECTION; ONE OF THEM WAS SAVED, AND THE OTHER ONE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296519 ↗
• MalfunctionJun 19, 2025Degraded; Degraded

  AS REPORTED, WHEN INSERTING A 4F 90 CM TEMPO PIGTAIL (PIG) CATHETER INTO AN UNKNOWN SHEATH, THE PART ATTACHED TO THE HUB CAME LOOSE AND WAS BROKEN. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. ONLY ONE DEVICE WAS USED IN THE PATIENT. THIS DEVICE DID NOT HAVE ANY PARTICLES NOTED. ALL THE ONES FROM THE SAME BATCH WERE COLLECTED, AND BASED ON THE ADDITIONAL INFORMATION RECEIVED, TWO (2) STERILE DEVICES HAD PARTICLES INSIDE THE SEALED PACKAGING AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE INVOLVED THE LEGS. THE TERM ¿LOOSE AND BROKEN¿ REFERRED TO A SPLIT IN AN AREA OF THE DEVICE. THE DAMAGE OBSERVED WAS DESCRIBED AS "FRAYED, SPLIT, OR TORN" AND WAS NOTICED DURING USE IN THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND NO DAMAGE WAS NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING, WHICH WAS PREPPED PER THE IFU WITHOUT ANY ISSUES. ANOTHER TEMPO CATHETER WAS NOT USED TO COMPLETE THE PROCEDURE, SINCE TWO WERE FOUND TO CONTAIN PARTICLES INSIDE THE PACKAGING UPON INSPECTION; ONE OF THEM WAS SAVED, AND THE OTHER ONE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293744 ↗