DiamondTemp™ Bidirectional Ablation Catheter CEDTB300S (UDI 00763000482121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000482121), received between Nov 7, 2021 and Jan 11, 2023 — classified as 4 injuries, 2 malfunctions.

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 16, 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.

• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, HEMATOMA AT THE ACCESS SITE IN THE GROIN OCCURRED. MEDICATION WAS ADMINISTERED FOR THE HEMATOMA. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Hematoma; Pain; Thrombosis/Thrombus

  MAUDE report 16139390 ↗
• InjuryNov 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, A STEAM POP OCCURRED DURING THE ABLATION OF THE LEFT PULMONARY VEINS. IT WAS NOTED THAT THE PHYSICIAN WAS DRAGGING THE CATHETER WHILE ABLATING. THE PATIENT'S BLOOD PRESSURE WAS MONITORED AND NO SIGNIFICANT DROPS WERE NOTED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759212 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TEN DAYS POST A RADIOFREQUENCY PROCEDURE THE PATIENT REPORTED CHEST DISCOMFORT AND ATRIAL FLUTTER DEVELOPED. AN INTERVENTIONAL PROCEDURE TOOK PLACE AND A CARDIOVERSION WAS CARRIED OUT TO CONVERT THE PATIENT BACK TO SINUS RHYTHM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Flutter; Chest Pain

  MAUDE report 15300857 ↗
• InjuryAug 3, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, A STEAM POP OCCURRED DURING THE ABLATION OF THE LEFT PULMONARY VEINS. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155822 ↗
• MalfunctionFeb 1, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, NOISE WAS DETECTED BY THE RF CATHETER ON THE DISTAL ELECTRODE. TWO ELECTROGRAMS (EGM) CABLES WERE ADDED TO THE SYSTEM, BUT THE ISSUE PERSISTED. IT WAS ALSO REPORTED THAT A STEAM POP OCCURRED. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415878 ↗
• MalfunctionNov 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, A STEAM POP OCCURRED WHILE ABLATING THE CAVOTRICUSPID ISTHMUS. THE CASE WAS ABLE TO BE COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759496 ↗

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-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-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-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-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-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
• 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