Infinity 5 Implantable Pulse Generator REF 6660 Product Description:… — Class I medical device recall Z-2510-2023
Ongoing recall by Abbott Medical, reported 2023-09-20, distributed nationwide. Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on the
| Recall number | Z-2510-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Plano, TX, United States |
| Recall initiated | 2023-07-18 |
| Classified | 2023-09-11 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HU, IE, IL, IN, IQ, IT, JP, KW, LT, LU, MX, NL, NO, NZ, PK, PL, PT, SA, SE, SG, SI, TR, TW, ZA |
| UPC / GTIN / UDI-DI | 05415067030016 |
| Serial numbers | 004.1, 024.1, 046.1, 056.1, 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 and 475 more |
| Model numbers | 192.1, 6660, CAV718.1, CAV738.1, CAX043.1, CAX105.1, CAX170.1, CAX273.1, CAX460.1, CAY169.1, CAY238.1, CAY243.1, CBA332.1, CBA370.1, CBB249.1, CBB260.1, CBB278.1, CBB304.1, CBB433.1, CBB475.1, CBB500.1, CBC244.1, CBC254.1, CBC259.1, CBC280.1 and 335 more |
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 for recall
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2510-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.