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Blazer® II M0045770TK20

by Boston Scientific

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared PMA P920047; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729200055 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0202-2019 FDA Class II initiated 20 Jun 2018 on shared PMA P920047

    Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

    • Terminated Z-0973-2011 FDA Unclassified (pre-2012) initiated 14 Jul 2009

    Product malfunction causes inadvertent delivery of energy.

    • Terminated Z-1617-2008 FDA Unclassified (pre-2012) initiated 14 Feb 2008 on shared PMA P920047

    Package sterile barrier may be breached, compromising sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Blazer® II
Generic Name
Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog
M0045770TK20
Primary DI / UDI-DI
08714729200055
PMA Number
FDA Product Code
LPB
GMDN Term
Cardiac radio-frequency ablation system catheter
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P920047)

Show all (12)

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No