Blazer® II XP M0044500THK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729452287), received between Jan 18, 2017 and Jul 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (P020025); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE POWER COULD NOT BE INCREASED TO 40W. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER, A BLAZER II XP WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, DURING PREPARATION, IT WAS NOTED THAT THE POWER COULD NOT BE INCREASED TO 40W. THERE WAS NO ERROR MESSAGE DISPLAYED. SUBSEQUENTLY, ANOTHER BLAZER CATHETER WAS USED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS CONTAMINATED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645759 ↗
• MalfunctionApr 15, 2021Temperature Problem; Temperature Problem

  DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER A BLAZER II XP CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT THE TEMPERATURE REACHED 70 DEGREES CELSIUS AND IT COULD NOT BE CONTROLLED BY THE PHYSICIAN. THE PROCEDURE WAS HALTED AND THE CATHETER WAS EXCHANGED FOR ANOTHER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674154 ↗
• MalfunctionJun 26, 2019Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE CURVE WOULD NOT STRAIGHTEN. DURING A RIGHT ATRIAL FLUTTER PROCEDURE INVOLVING A BLAZER II XP CATHETER WHILE INSIDE THE BODY, THE CATHETER RETAINED THE CURVE AND IT WOULD NOT STRAIGHTEN OUT AND STAYED CURVED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS TO THE PATIENT AND WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735229 ↗
• MalfunctionMay 22, 2018Charred; Charred

  IT WAS REPORTED THAT CHAR WAS NOTED AT THE TIP OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE RIGHT ATRIUM. A 7 / 110 / 2.5 / 8-8 QD K2 BLAZER PRIME® XP ABLATION CATHETER WAS SELECTED FOR RIGHT ATRIAL FLUTTER ABLATION. DURING PROCEDURE, THE RUNNING PARAMETERS WERE NORMAL, THE POWER WAS AT 80 WATTS AND THE TEMPERATURE WAS 65. HOWEVER, WHEN THE CASE WAS COMPLETED AND THE CATHETER WAS THEN REMOVED FROM THE PATIENT'S BODY, A CHAR ON THE TIP OF THE CATHETER WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7532686 ↗
• MalfunctionFeb 7, 2018Failure to Sense; Failure to Sense

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-JAN-2018. IT WAS REPORTED THAT NO SIGNAL OCCURRED. A BLAZER® II XP WAS SELECTED FOR USE. DURING PROCEDURE, WHEN THE BLAZER® WAS INSERTED INTO THE BODY AND THE CABLE WAS CONNECTED, IT WAS NOTED THAT THERE WAS NO ELECTRICAL SIGNALS. THE PHYSICIAN ATTEMPTED TO REPLACE THE CABLE; HOWEVER, ISSUE WAS NOT RESOLVED. FINALLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SEALS ON RING 2 AND RING 3 WERE COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7248263 ↗
• MalfunctionJan 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-JAN-2018. IT WAS REPORTED THAT THE CATHETER CURVE WOULD NOT STEER PROPERLY. A 7 / 110 / 2.5 / 8-8 BLAZER® II XP WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER CURVE WOULD NOT STEER PROPERLY IN ONE DIRECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SEALS OF RINGS 2 AND 3 WERE COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7219860 ↗
• MalfunctionDec 18, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-DEC-2017. IT WAS REPORTED THAT A CATHETER STEERING ISSUE OCCURRED. A 7 / 110 / 2.5 / 8-8 QD K2 HTD BLAZER® II XP ABLATION CATHETER WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE DIRECTION OF THE CATHETER WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS RESULTS REVEALED THE RING 2 SEAL WAS COMPROMISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126257 ↗
• MalfunctionJan 18, 2017Failure to Deliver Energy; Failure to Deliver Energy

  REPORTABLE UPON ANALYSIS COMPLETED ON 22DEC2016. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ABLATE. A 7 / 110 / 2.5 / 8-8 QD K2 HTD BLAZER II XP WAS SELECTED TO TREAT THE LESION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNABLE TO ABLATE. THE TEMPERATURE WAS READING AT 130 AND WAS UNABLE TO DELIVER POWER. PHYSICIAN RESET SYSTEM AND CHANGED CABLES BUT IT DID NOT CHANGE. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A CHAR ON THE DISTAL TIP WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260142 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020025. 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,