Abbott Proclaim 5 Implantable Pulse Generator Service Life Shorter Than Labeled
Abbott's Proclaim 5 implantable pulse generator may reach end of service sooner than indicated in product labeling. The time between the elective replacement indicator threshold and complete device failure may be shorter than documented.
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: FDA Class II recall of an implantable medical device where premature service termination creates risk of harm due to loss of therapy and need for replacement surgery. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Abbott Medical is recalling 1,379 units of the Abbott Proclaim 5 Implantable Pulse Generator (IPG), model REF 3661. This implantable device has been distributed worldwide, including throughout the United States and 37 additional countries.
The device's actual service duration may be shorter than indicated in the product labeling. Specifically, the time between when the device reaches its elective replacement indicator threshold and when it reaches end of service may be shorter than stated in manufacturer documentation. This means the device could fail sooner than patients and clinicians expect based on the labeling.
Patients with an implanted Proclaim 5 generator should contact their healthcare provider to discuss their device and ensure appropriate monitoring. Clinicians should review patient records to identify affected units by serial number and plan for timely device replacement as needed.
The recalled product
- Product
- Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Category
- Medical Device
- Hazard
- premature-end-of-service
- labeling-inaccuracy
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:05415067020208/ All Serial Numbers
Distribution
Distributed nationwide across the United States.
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