Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error
Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.
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 a Class II medical device recall with no reported injuries or hospitalizations. It involves a risk-of-harm medical device where an implantable pulse generator may reach end of service sooner than labeled, potentially disrupting expected patient therapy. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Abbott Medical is recalling the Proclaim XR 5 Implantable Pulse Generator (REF 3660), affecting approximately 83,511 units distributed worldwide, including throughout the United States and multiple countries.
The duration between when the device reaches its elective replacement indicator (ERI) threshold and when it reaches end of service may be shorter than indicated in the product labeling. This means the implantable pulse generator battery may deplete sooner than patients and physicians expect based on the labeled timeline.
The recall affects patients worldwide who have received this device across all US states, US territories, and multiple international locations.
Patients with this device should contact their healthcare provider or Abbott Medical for guidance on their specific situation and any necessary device monitoring and replacement planning.
The recalled product
- Product
- Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Affected units
- 83,511
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 05415067031419/ All Serial Numbers
Distribution
Part of a larger recall action
This product is one of 12 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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