FDA Device recall Z-2510-2023
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed…
- FDA Device
- Class I
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class I recall of Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed… by Abbott Medical, citing firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2510-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-07-18 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).
Reason
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Identifiers
| code_info | Model Number: 6660 UDI-DI Codes: 05415067030016 Serial Numbers: US AAD255.1 AAN997.1 AAP328.1 AAT540.1 AAT579.1 AAT652.…Model Number: 6660 UDI-DI Codes: 05415067030016 Serial Numbers: US AAD255.1 AAN997.1 AAP328.1 AAT540.1 AAT579.1 AAT652.1 AAT772.1 AAT783.1 AAT795.1 AAT797.1 AAT845.1 AAT902.1 AAT989.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABM541.1 ABM592.1 ABM630.1 ABT798.1 ABT829.1 ABT841.1 ABT900.1 ACD800.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE936.1 ACE939.1 ACE994.1 ACF048.1 ACK145.1 ACK161.1 ACK241.1 ACK511.1 ACK514.1 ACK549.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP686.1 ACP700.1 ACP712.1 ACP770.1 ACP780.1 ACP835.1 ACP869.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACT738.1 ACU349.1 ACU381.1 ACU424.1 ADR673.1 ADR679.1 ADR685.1 ADR787.1 ADR794.1 ADR852.1 ADR856.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH877.1 AEH883.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ111.1 AEJ145.1 AEJ164.1 AEJ167.1 AEJ196 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-11-19 · Abbott Medical - Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
FDA Device · Class II · 2025-11-19 · Abbott Medical - Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Ave…
FDA Device · Class II · 2025-04-23 · Abbott Medical - The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates u…
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2510-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.