Abbott Aveir Leadless Pacemaker May Experience Mode Changes Due to Electromagnetic Interference
Abbott Medical is recalling certain Abbott Aveir Leadless Pacemakers due to potential electromagnetic interference that could cause mode changes. The recall affects 10,610 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device (pacemaker) where electromagnetic interference presents a theoretical risk of malfunction (mode change). The source text indicates no reported illnesses or injuries to date, placing it in the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abbott Medical is recalling the Abbott Aveir Leadless Pacemaker, model LSP112V, distributed nationwide in the United States. Approximately 10,610 units are included in this recall.
The pacemaker is being recalled because of a potential risk that electromagnetic interference could cause the device to experience a mode change. The malfunction could affect the normal operation of the device.
This recall affects patients who received the recalled pacemaker models. The devices were distributed to healthcare facilities and patients across numerous states.
Patients with one of the recalled devices should contact Abbott Medical and consult with their physician regarding this issue. Healthcare providers should review the recall details and discuss any concerns with affected patients.
The recalled product
- Product
- Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
- Manufacturer
- Abbott Medical
- Hazard
- electromagnetic-interference
- mode-change
- device-malfunction
Distribution
Distributed nationwide across the United States.
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