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Farastar™ M004PF61M403

by Boston Scientific

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

5 ongoing

This device is named in the recall

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 Number00191506057688 UDI-DI Date20 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · 5 ongoing · FDA

    • Ongoing Z-2753-2026 FDA Class II initiated 11 Jun 2026

    Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

  • 3 recalls, same reason

    • Ongoing Z-2750-2026 FDA Class II initiated 11 Jun 2026
    • Ongoing Z-2752-2026 FDA Class II initiated 11 Jun 2026
    • Ongoing Z-2751-2026 FDA Class II initiated 11 Jun 2026

    Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

    • Ongoing Z-2278-2025 FDA Class II initiated 25 Jun 2025

    The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Farastar™
Generic Name
Cardiac irreversible electroporation system generator
Model / Ref / Catalog
M004PF61M403
Primary DI / UDI-DI
00191506057688
PMA Number
FDA Product Code
QZI
GMDN Term
Cardiac irreversible electroporation system generator
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P230030)

Show all (12)

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No