Blazer Prime® HTD M004P5031THK20Recalls & reported problems
Boston Scientific Corporation · Temperature Ablation Catheter · Class 3
Data updated Oct 18, 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 08714729803591), received between Dec 21, 2016 and Dec 21, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unable to Obtain Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Unable to Obtain Readings1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2016Unable to Obtain Readings; Unable to Obtain Readings
REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED ON DECEMBER 5, 2016. IT WAS REPORTED THAT NO ELECTROGRAMS DISPLAYED. THE TARGET LOCATION WAS THE RIGHT ATRIUM. DURING THE PROCEDURE, NO ELECTROGRAMS WERE DISPLAYING FROM THE BLAZER PRIME® HTD CATHETER AND THE CABLE HAD NOISE. THE NOISE WAS RESOLVED WITH EXCHANGING THE CABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED FLUID UNDER RING SEAL 1 AND A BLUE FIBER ENCASED IN THE SEAL OF R3.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6196040 ↗
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, ClassifiedBoston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
- Z-0973-2011 · Jul 14, 2009 · TerminatedRF 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 · TerminatedBoston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page