TEMPO 451543H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032008662), received between Mar 28, 2018 and Jan 21, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE WAS HAIR INSIDE THE PACKAGE OF THE 5F SMALL ADULT (C2) 100CM TEMPO DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER CONTRAST CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE STERILE POUCH WAS NOT RECEIVED OPEN OR COMPROMISED. THE CONDITION WAS NOTED PRIOR TO USING THE DEVICE. IT WAS STORED IN A CABINET IN THE LAB. THE ACTUAL PRODUCT WAS NOT DAMAGED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21198251 ↗
• MalfunctionMay 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, THERE WAS A HAIR INSIDE THE PACKAGING OF A 5F COBRA 2 (C2) 100CM TEMPO ANGIOGRAPHIC CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THE PACKAGING OF THE CATHETER WAS NOT OPENED AND THE STERILE POUCH WAS NOT RECEIVED OPENED. THE DEVICE WAS NEVER USED OR RESHELVED. THE CONDITION WAS NOTED UPON INITIAL RECEIPT OF DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860713 ↗
• InjuryDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A TEMPO 5F COBRA 2 100CM CATHETER BROKE OFF IN THE PATIENT, AND THE TIP REMAINED IN THE PATIENT. THE DEVICE SEPARATED INSIDE THE PATIENT AND THE SEGMENT WAS NOT RETRIEVED. THE INTENDED PROCEDURE WAS AORTIC STENTING WITH A GRAFT. THERE WAS VESSEL TORTUOSITY. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS STORED AND PREPPED PER INSTRUCTIONS FOR USE (IFU) AND OPENED IN A STERILE FIELD. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. X RAY IMAGE OF AN ARROW POINTING TO THE DISTAL PORTION OF A CATHETER, WHICH APPEARS SEPARATED. THE PRESENCE OF A STENT IS ALSO VISUALIZED AND THE SEPARATED CATHETER PIECE IS LOCATED WITHIN THE AREA OF THE STENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16000028 ↗
• InjuryDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A 5F COBRA - SMALL ADULT (C2) 100CM TEMPO CATHETER BROKE OFF IN THE PATIENT. THE PHYSICIAN HAS BEEN ABLE TO RECOVER THE BROKEN PIECE. THE SEPARATED PIECE WAS REMOVED THROUGH AN UNKNOWN SNARE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE INTENDED PROCEDURE WAS AORTIC STENTING GRAFT. NO DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE ARE NO PROCEDURAL IMAGES AVAILABLE FOR REVIEW. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974243 ↗
• MalfunctionMar 28, 2018Detachment Of Device Component; Detachment Of Device Component

  BEFORE USE, IT WAS REPORTED THAT THE LUER LOCK CONNECTION ON TWO TEMPO CATHETERS WERE BROKEN (THE LUER HUB WAS IN SINGLE PIECES). THERE WAS NO PATIENT INJURY. THE PRODUCTS ARE STILL ORIGINALLY PACKED AS THE DEVICES WERE NEVER REMOVED FROM THE PACKAGE. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377509 ↗
• MalfunctionMar 28, 2018Detachment Of Device Component; Detachment Of Device Component

  BEFORE USE, IT WAS REPORTED THAT THE LUER LOCK CONNECTION ON TWO TEMPO CATHETERS WERE BROKEN (THE LUER HUB WAS IN SINGLE PIECES). THERE WAS NO PATIENT INJURY. THE PRODUCTS ARE STILL ORIGINALLY PACKED AS THE DEVICES WERE NEVER REMOVED FROM THE PACKAGE. THERE WERE NO DAMAGES TO THE DEVICE PACKAGING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377506 ↗