DiamondTemp™ Unidirectional Ablation Catheter CEDT200LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000482114), received between Jan 26, 2022 and Sep 16, 2022 — classified as 3 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 18, 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.

• MalfunctionSep 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, TWO INCIDENCES OF STEAM POP OCCURRED. THE CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. 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 15442258 ↗
• MalfunctionMar 10, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY PROCEDURE, A STEAM POP OCCURRED. IT WAS ALSO REPORTED THAT THE RADIOFREQUENCY CATHETER COULD NOT MAINTAIN A FULL DEFLECTION. THE RADIOFREQUENCY CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. 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 13726248 ↗
• MalfunctionJan 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, TWO STEAM POPS OCCURRED AT THE END OF THE CASE. 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 13358255 ↗

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-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
• 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-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-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