Blazer® II HTD M0045031THK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729172055), received between Jul 11, 2017 and Mar 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (P920047); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Perforation

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. DURING A PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT), A BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS USED. IT WAS OBSERVED THAT THE CATHETER WAS FRACTURED. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24709244 ↗
• MalfunctionNov 28, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE ENERGY DID NOT INCREASE. A BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE. IT WAS NOTED THAT THE ENERGY DID NOT INCREASE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE HAS BEEN RECEIVED AND ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23672102 ↗
• MalfunctionMar 6, 2024Temperature Problem; Temperature Problem

  THE BLAZER II HTD TEMPERATURE ABLATION CATHETER WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA. IT WAS REPORTED THAT THE TEMPERATURE WOULD FLUCTUATE MULTIPLE TIMES. AFTER THE TEMPERATURE ROSE ABOVE 70 DEGREES, THEY SLOWLY TURNED IT ON, BUT THE POWER WAS FIXED AT 10WATT AND THEY DID NOT SEE ANY RISE. A DIFFERENT DEVICE WAS USED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXCEPTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849398 ↗
• MalfunctionSep 21, 2020Positioning Problem; Temperature Problem; Positioning Problem; Temperature Problem

  IT WAS REPORTED THAT A BLAZER II HTD WAS USED IN A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THE DISTAL TIP TEMPERATURE WAS NOT STABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLAZER WITH NO PATIENT COMPLICATIONS BEING REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10561161 ↗
• MalfunctionOct 10, 2017Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-SEP-2017. IT WAS REPORTED THAT SIGNAL INTERFERENCE AND IMAGE ISSUES OCCURRED. THE TARGET LESION WAS LOCATED NEAR THE TRICUSPID VALVE. A BLAZER® II HTD WAS SELECTED FOR USE. DURING THE PROCEDURE, AS THE CATHETER WAS CONNECTED, SIGNAL INTERFERENCE WAS NOTED. ALSO, THE IMAGE WAS NOT SHOWN ON THE SCREEN. THE DEVICE WAS REMOVED FROM THE SWARTZ SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A FOREIGN MATTER WAS NOTED ON THE DEVICE. ALSO, THE SEALS TO BOTH RING 1 AND 2 ELECTRODES WERE COMPROMISED. IT WAS FURTHER REPORTED THAT THE FOREIGN MATTER WAS NOT OBSERVED DURING OR AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6936099 ↗
• MalfunctionJul 11, 2017Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-JUN-2017. IT WAS REPORTED THAT THERE WAS NO SIGNAL FROM THE CATHETER DISTAL TIP SIDE. A BLAZER® II HTD WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WERE NO SIGNAL FROM THE DISTAL TIP SIDE OF THE CATHETER. FURTHERMORE, THE CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE DEVICE WAS REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A FOREIGN STICKY SUBSTANCE ON THE DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6701353 ↗
• MalfunctionJul 11, 2017Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2017. IT WAS REPORTED THERE WAS NO SIGNAL FROM THE CATHETER DISTAL TIP SIDE. A BLAZER¿I HTD WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS NO SIGNAL FROM THE DISTAL TIP SIDE OF THE CATHETER. FURTHERMORE, THE CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A FOREIGN STICKY SUBSTANCE ON THE DISTAL TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6701021 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P920047. One submission often covers many models, so check the product and lot details in each record.

• Z-0202-2019 · Jun 20, 2018 · Open, Classified
  Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
• Z-0973-2011 · Jul 14, 2009 · Terminated
  RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. Intended use: The EPT-1000
• Z-1617-2008 · Feb 14, 2008 · Terminated
  Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (