FDA Device recall Z-2505-2023
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implant…
- FDA Device
- Class I
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class I recall of Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implant… 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-2505-2023 |
| 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
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 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: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 A…Model Number: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD337.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP039.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 AAP123.1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2505-2023%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.