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DiamondTemp™ Bidirectional Ablation Catheter CEDTB400LRecalls & reported problems

Medtronic, Inc. · CATH CEDTB400L BIDIR LG CURVE US 2Y · Class 3

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000747121), received between May 23, 2023 and May 23, 2023 — classified as 1 malfunction.

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

Device problems

  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) ABLATION PROCEDURE, STEAM POP WAS NOTED. 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 16989308 ↗

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-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-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-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-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-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

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Sources and updates

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