Abbott Medical Recall: Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Descri
Abbott Medical Recall: Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Descri is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Abbott Medical; Product: Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an elec
| Recalling firm | Abbott Medical |
|---|---|
| Product | Proclaim Plus 5 Implantable Pulse Generator REF 3670 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 pr |
| 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). |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The count |
| Recall initiated | 20230718 |
| Recall number | Z-2507-2023 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
Try RecallGuard →