Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode
Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of a critical implantable medical device with reported patient complaints of functional malfunction. Per the rubric, FDA Class I recalls require a minimum severity score of 4.
Plain-English summary
Abbott Medical has recalled the Proclaim XR 5 Implantable Pulse Generator (Model 3660) because some patients have reported being unable to exit MRI mode on their devices.
The issue involves the device's MRI mode functionality. Patients have submitted complaints indicating that their implanted pulse generators cannot exit MRI (Magnetic Resonance Imaging) mode, which is designed to be a temporary setting for medical imaging procedures.
Approximately 113,784 devices have been recalled, including 95,226 units in the United States and 18,558 overseas. The devices are distributed nationwide across all U.S. states and territories, as well as in over 40 countries worldwide.
Patients with affected devices should contact their healthcare provider or Abbott Medical for guidance. Your doctor can verify whether your device is included in this recall and advise you on next steps. Do not proceed with MRI procedures until you have confirmed your device's status with your healthcare provider.
The recalled product
- 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…
- Manufacturer
- Abbott Medical
- Hazard
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.
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