Reported Sep 20, 2023 · Ongoing

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an…

Abbott Medical

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Abbott Medical · 6901 Preston Rd · Plano, TX · 75024-2508

Proclaim Plus 7 Implantable Pulse
Generator REF 3672 Product DescriptionThe 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)

Lot codes and dates: Model Number3672
UDI-DI Codes05415067046406
Serial NumbersUS
387 of 387 codes
CBW328.1
CCA167.1
CCA177.1
CCU613.1
CCV760.1
CCX700.1
CCY890.1
CDR307.1
CDW220.1
CEC548.1
CEC719.1
CEE095.1
CEH111.1
CEH156.1
CEH200.1
CEH272.1
CEH293.1
CEH334.1
CEH964.1
CEH975.1
CEH993.1
CEK127.1
CEK258.1
CEK265.1
CEK271.1
CEK310.1
CEK432.1
CEM232.1
CEM340.1
CEM349.1
CEM375.1
CEM383.1
CEM396.1
CEN429.1
CEN444.1
CEP494.1
CEP497.1
CEP537.1
CEP540.1
CEP541.1
CEP553.1
CEP554.1
CEP562.1
CEP585.1
CEP645.1
CEP658.1
CEP663.1
CEP671.1
CEP685.1
CEP725.1
CEP730.1
CEP838.1
CEP847.1
CEP867.1
CER393.1
CER395.1
CER462.1
CER482.1
CER509.1
CER576.1
Amount recalled: 387 devices (US only)

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Stop using this product now

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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14 in total.