Abbott Proclaim DRG implantable pulse generator service life shorter than labeled
Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 involving a risk-of-harm medical device (implantable pulse generator) with a labeling discrepancy regarding critical service life information. No reported injuries or illnesses have been documented. The issue poses potential risk if the device fails sooner than expected without timely replacement.
Plain-English summary
Abbott Medical is recalling 21,843 units of the Proclaim DRG Implantable Pulse Generator (REF 3664) due to a discrepancy between the actual service life and the duration described in product labeling.
The issue involves the time span between when the device reaches the elective replacement indicator threshold and when it reaches end of service. This duration may be shorter than what is indicated in the product labeling. Patients and healthcare providers rely on this timing information to schedule device replacement procedures.
The recalled units were distributed worldwide, including throughout the United States and multiple international markets. The device is an implantable pulse generator used for medical treatment.
Patients and healthcare providers with these devices should contact Abbott Medical for guidance on device management and potential replacement. Healthcare facilities should review their patient registries for affected units and take appropriate clinical action.
The recalled product
- Product
- Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Affected units
- 21,843
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)
- 05415067020215/ 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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