Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled
Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.
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 FDA Class II recall involves an implantable medical device with inaccurate service-life labeling. Although no adverse events are reported, the shortened service life creates a risk of harm to patients relying on the labeled duration. This meets the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Abbott Medical is recalling the Proclaim XR 7 Implantable Pulse Generator (REF 3662). The device may reach end of service sooner than indicated in the product labeling.
The time between when the device reaches the elective replacement indicator threshold and when it stops functioning may be shorter than the labeling states. This means patients and doctors relying on the labeled service duration may not plan for device replacement in time.
Approximately 9,006 units have been distributed worldwide, including throughout the United States and many international locations.
Patients with this device should contact their healthcare provider to discuss the situation and review replacement timing. Do not stop using the device without medical guidance.
The recalled product
- Product
- Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Hazard
- premature-failure
- labeling-error
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:05415067031426/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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