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Afr-00006

by Medtronic, Inc.

Ref AFR-00006

Afr-00006 is a device classified as Class I in the EU and Class III in the US made by Medtronic, Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 0763000B00026268C), approved under FDA PMA P240013 on 24 Oct 2024 and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 00763000871796), active as of 23 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P240013

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00026268C Basic UDI-DI 00763000871796UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000871796 UDI-DI Date4 Nov 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP240013 Date24 Oct 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00026268C registered 7 May 2026 Active
  • FDA PMA P240013 decided 24 Oct 2024 Active
  • FDA GUDID UDI-DI 00763000871796 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

4 dated events

  1. Approved FDA PMA P240013
  2. Listed FDA GUDID 00763000871796
  3. Recall initiated FDA recalls Z-1948-2026
  4. Registered EUDAMED 0763000B00026268C

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Electrical-only medical device connection cable, single-use
Device name
Extension Cable
Model / reference
AFR-00006
Primary DI / UDI-DI
00763000871796 EUDAMED
00763000871802 GUDID
Basic UDI-DI
0763000B00026268C
PMA number
FDA product code
QZI, OAD, OAE
EMDN code
C020180 Cardiac electrophysiology and mapping devices - accessories
GMDN term
Electrical-only medical device connection cable, single-use
Device class
Class I EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000871796
GUDID
00763000871802
Device classEUDAMED
Class I
GUDID
Class III

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000871796; FDA GUDID lists 00763000871802), so their flags are not compared. Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrical-only medical device connection cable, single-use

Cleared under the same submission (P240013)

and 8 more cleared under P240013

Similar devices in this category

Other devices filed under CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)