Blazer® II M0045031TK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729199939), received between May 1, 2018 and Mar 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 18, 2022Failure to Deliver Energy; Failure to Deliver Energy

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24FEB2022. IT WAS REPORTED THAT DURING A CARDIAC RADIOFREQUENCY ABLATION PROCEDURE, A BLAZER II CATHETER HAD POOR CONTACT AND COULD NOT DISCHARGE. THERE WERE NO ISSUES REGARDING TEMPERATURE. THE CATHETER WAS DISCHARGED INTERMITTENTLY AND COULD NOT BE USED NORMALLY. NO ERROR MESSAGES. TEMPERATURE CONTROL MODE WAS IN USE. PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT INJURY REPORTED. DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE IS A CUT IN THE DISTAL PART OF THE CATHETER SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13805346 ↗
• MalfunctionNov 27, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT FEORGIN MATERIAL WAS FOUND INSIDE THE PACKAGING. DURING PREPARATION WHEN THEY OPENED THE BLAZER CATHETER, THEY FOUND THAT THE PACKAGE CONTAINED DIRT/TRASH INSIDE THE BAG. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9385150 ↗
• MalfunctionMay 1, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04-APRIL-2018. IT WAS REPORTED THAT TEMPERATURE DOES NOT RISE ANYMORE AT 37DEGREE. A 7/110/2.5/7-4 BLAZER® II ABLATION CATHETER WAS SELECTED FOR TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT). DURING PROCEDURE, IT WAS NOTED THAT THE TEMPERATURE WOULD NOT RISE MORE THAN 37 DEGREES. THE GENERATOR WAS CHECKED; HOWEVER, THE TEMPERATURE STILL WOULD NOT RISE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS GOOD. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE THERMISTOR WAS SEPARATED FROM THE TIP AND WAS RETRACTED APPROXIMATELY 4CM BACK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7475212 ↗

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 (