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Afr-00002

by Medtronic, Inc. 2 variants

Afr-00002 is a Class III device made by Medtronic, Inc., approved under FDA PMA P240013 on 24 Oct 2024 and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 00763000871772), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P240013

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000871772 UDI-DI Date4 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP240013 Date24 Oct 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P240013 decided 24 Oct 2024 Active
  • FDA GUDID UDI-DI 00763000871772 listed 4 Nov 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1948-2026 FDA Class II initiated 11 Mar 2026

    Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.

Timeline

3 dated events

  1. Approved FDA PMA P240013
  2. Listed FDA GUDID 00763000871772
  3. Recall initiated FDA recalls Z-1948-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Generic name
Cardiac ablation system irrigation tubing set
Model / reference
AFR-00002
Primary DI / UDI-DI
00763000871772
PMA number
FDA product code
OAD, QZI, OAE
GMDN term
Cardiac ablation system irrigation tubing set
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac ablation system irrigation tubing set

Cleared under the same submission (P240013)

and 8 more cleared under P240013

Similar devices in this category

Other devices filed under Cardiac ablation system irrigation tubing set.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)