Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency, which requires a minimum severity score of 4. Although no specific illnesses or injuries have been reported in the source text, the device malfunction—inability to exit MRI mode—poses a serious risk to patients relying on this critical implantable device.
Plain-English summary
Abbott Medical is recalling certain Proclaim Plus 5 Implantable Pulse Generators (IPGs), Model 3670, serial numbers listed by the manufacturer. These are implantable medical devices used to provide electrical stimulation for treatment of chronic pain, movement disorders, and other neurological conditions.
The firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs. This malfunction prevents the devices from functioning normally after MRI imaging, creating a risk of serious harm to patients.
The FDA has classified this as a Class I recall. Approximately 2,242 devices have been distributed in the United States as of the recall announcement.
The recalled product
- 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 w
- Manufacturer
- Abbott Medical
- Category
- Medical Device
- Affected units
- 2,242
Distribution
Part of a larger recall action
This product is one of 7 recalled by Abbott Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Abbott Medical
See all →- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighDeep brain stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- HighSpinal cord stimulators recalled over loss of programmer communication
FDA (Devices) · 2025-11-19
- HighAbbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk
FDA (Devices) · 2025-04-23
- HighMerlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
FDA (Devices) · 2025-01-01
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighNeuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12