Blazer Prime® XP M004P4500THK20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729802334), received between Dec 12, 2017 and Jul 2, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2019Mechanics Altered; Positioning Problem; Mechanics Altered; Positioning Problem

  REPORTABLE UPON ANALYSIS COMPLETED ON 04JUN2019. IT WAS REPORTED THAT POOR CURVE AND DEFLECTION ISSUES OCCURRED. A BLAZER PRIME WAS SELECTED FOR A PROCEDURE, HOWEVER IT WAS NOTICED DURING THE PROCEDURE THAT THE CATHETER HAD AN IRREGULAR CURVE SHAPE AND THEN THE CATHETER WOULDN'T CURVE CORRECTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME WITH NO PATIENT COMPLICATIONS OCCURRING. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BROKEN RING ADHESIVE AND FLUID INGRESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752374 ↗
• MalfunctionJun 13, 2019Material Integrity Problem; Mechanics Altered; Material Integrity Problem; Mechanics Altered

  IT WAS REPORTED THAT THE CATHETER TIP WAS SEVERELY BROKEN/DAMAGED. DURING AN ABLATION PROCEDURE, A BLAZER PRIME XP WAS BEING USED FOR A MYOCARDIAL ABLATION TO TREAT ATRIAL FLUTTER (AFL) IN THE RIGHT INGUINAL REGION. AFTER CAUTERIZING/ABLATING THE ISTHMUS AN ABNORMALITY IN THE BENDING OF THE CATHETER WAS FELT, AND WHEN IT WAS TAKEN OUT OF THE PATIENT, THE CATHETER TIP WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8697361 ↗
• MalfunctionJun 6, 2019Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03JUN2019. IT WAS REPORTED THAT THE CATHETER WAS DEFECTIVE. DURING A PROCEDURE WITH A BLAZER PRIME XP "IT WAS A BAD CATHETER, IT WOULDN'T WORK". THEY FINISH THE CASE WITH ANOTHER CATHETER OF THE SAME SIZE. NO PATIENT COMPLICATIONS OCCURED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BROKEN ADHESIVE ON RING #2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674993 ↗
• MalfunctionJan 10, 2019Mechanics Altered; Positioning Problem; Mechanics Altered; Positioning Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 14-DEC-2018. IT WAS REPORTED THAT LOSS OF STEERING OCCURRED. A BLAZER PRIME XP WAS SELECTED FOR A PROCEDURE HOWEVER THE TIP AND THE STEERING ASPECT OF THE DEVICE WAS DEFECTIVE, THEY COULD NOT GET IT TO WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLAZER PRIME XP. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED FLUID INGRESS AND BROKEN ADHESIVE ON RING 1. ANALYSIS OF RETURNED PRODUCT REVEALED A KINK AT THE DISTAL SECTION CAUSED BY A BENT CENTER SUPPORT CONFIRMED AFTER DISSECTION; CONSEQUENTLY, CONFIRMING THE REPORTED COMPLAINT, THIS CONDITION OF THE CENTER SUPPORT COULD ALSO HAVE CAUSED THE INGRESS OF FLUIDS WITHIN THE DISTAL END. VISUAL INSPECTION FAILED DUE TO THE KINK AT THE DISTAL SECTION AND THE BROKEN ADHESIVE IN RING 1. DIMENSIONAL INSPECTION FAILED DUE TO THE CURVE FAILED TO REACH THE SPECIFIED AREA OF THE TEMPLATE AND THE SHORT KEVLAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8235448 ↗
• MalfunctionDec 18, 2017Charred; Charred

  IT WAS REPORTED THAT CHAR WAS NOTED AT THE TIP OF THE CATHETER. A 7-110-2.5-8-8 K2 BLAZER PRIME XP ABLATION CATHETER WAS SELECTED FOR ATRIAL FLUTTER ABLATION. DURING PROCEDURE, IMPEDANCE WAS NOTED TO HAVE SPIKED 3 TIMES AND HEAVY CHAR WAS NOTED ON THE TIP OF THE CATHETER. THE TIP OF THE CATHETER WAS CLEANED; HOWEVER, THE SAME ISSUE OCCURRED AND TEMPERATURE WOULD NOT PASS 36 DEGREES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126382 ↗
• MalfunctionDec 12, 2017Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-NOV-2017. IT WAS REPORTED THAT THE STEERING MECHANISM BROKE. THE TARGET LESION WAS LOCATED IN THE ATRIUM. A BLAZER PRIME® XP WAS SELECTED FOR USE. DURING PROCEDURE, THE STEERING MECHANISM BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT ALL SEALS ON THE ELECTRODES WERE COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7110197 ↗

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,