DiamondTemp™ Bidirectional Ablation Catheter CEDTB300S (UDI 00763000536688)Recalls & reported problems
Medtronic, Inc. · BIDIR CATH SM CURVE CEDTB300S US · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000536688), received between Mar 14, 2025 and Mar 14, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED POST-OPERATIVELY AFTER A RADIOFREQUENCY (RF) ABLATION PROCEDURE, BLEEDING OCCURRED IN THE RIGHT GROIN. PRESSURE WAS APPLIED TO THE AREA TO STOP THE BLEEDING. THE PATIENT WAS HOSPITALIZED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21604704 ↗
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-1319-2021 · Feb 22, 2021 · Open, ClassifiedEPIX 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-1317-2021 · Feb 22, 2021 · Open, ClassifiedEPIX 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-1322-2021 · Feb 22, 2021 · Open, ClassifiedEPIX 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-1318-2021 · Feb 22, 2021 · Open, ClassifiedEPIX 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-1321-2021 · Feb 22, 2021 · Open, ClassifiedEPIX 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-1320-2021 · Feb 22, 2021 · Open, ClassifiedEPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
Other Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation devices
- TactiCath™ A-TCSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall23 deaths923 reports
- TactiCath™ PN-004075St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation7 deaths338 reports
- TactiFlex™ Sensor Enabled™ A-TFSE-DFSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall6 deaths241 reports
- TactiCath™ A-TCSE-FJSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths174 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall3 deaths147 reports
- TactiCath™ A-TCSE-DSt. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation2 deaths175 reports
- TactiSys™ PN-004400St. Jude Medical, Inc. · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation1 recall125 reports
- QDOT MICRO D139402Biosense Webster Inc · Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation3 deaths171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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