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Farastar™

by Boston Scientific Corporation 27 variants

Ref M004PF61M415

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000537NG Basic UDI-DI 00191506042981UDI-DIDate22 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00191506042981 UDI-DI Date9 Feb 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Electrocardiographic lead set, reusable
Device Name
FARAPULSE PFA Capital Equipment Components
Model / Ref / Catalog
M004PF61M415
Primary DI / UDI-DI
00191506042981
Basic UDI-DI
01915060000000000000537NG
PMA Number
FDA Product Code
QZI
EMDN Code
C020399 Cardiac tissue ablation devices - other
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class III GUDID
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class III

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Guidant Europe NV/SA; Boston Scientific BE-AR-000008410

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No