DiamondTemp™ Bidirectional Ablation Catheter CEDTB300S (UDI 00763000747114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000747114), received between Oct 23, 2023 and Nov 20, 2023 — classified as 2 injuries.

6 other recalls cover devices cleared under the same FDA submission (P200028); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE PATIENT HAD EPISODES OF PAROXYSMAL ATRIAL FIBRILLATION (AF). THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO THE SYMPTOMS. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND SHOWED ATRIAL FIBRILLATION (AF). A NON-CARDIOSELECTIVE BETA-BLOCKER WAS STARTED. THE OUTCOME OF THIS CASE IS UNKNOWN. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Headache

  MAUDE report 18171306 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS FOLLOWING A COMPLETED RADIOFREQUENCY (RF) ABLATION PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED AFTER AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED WITH ATYPICAL FLUTTER. THE PATIENT WAS CARDIOVERTED PHARMACOLOGICALLY WITH A CALCIUM ANTAGONIST MEDICATION GIVEN INTRAVENOUSLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter

  MAUDE report 17985170 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200028. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
• Z-1321-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030
• Z-1318-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
• Z-1320-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
• Z-1319-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
• Z-1322-2021 · Feb 22, 2021 · Open, Classified
  EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 0081249903