Abbott Proclaim Plus 5 Pulse Generator Battery Life Shorter Than Labeled
Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.
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: This is an FDA Class II recall of an implanted medical device with a potential performance defect. No adverse events or injuries have been reported, but device failure could result in loss of therapeutic benefit. Per the rubric, risk-of-harm products where injury has not yet been reported receive a Score 3 (High).
Plain-English summary
Abbott Medical is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator (REF 3670). This is a surgically implanted medical device.
The FDA has determined that the duration between when the device reaches the elective replacement indicator threshold and its complete end-of-service may be shorter than indicated in the product labeling. This means the device's battery life may deplete faster than the healthcare provider and patient documentation indicates.
The affected devices were distributed worldwide, with distribution throughout the United States, including all 50 states and territories, and to multiple countries internationally.
Patients implanted with this device should contact their healthcare provider without delay to discuss appropriate management, which may include device replacement or closer monitoring of device status.
The recalled product
- Product
- Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Category
- Medical Device
- Affected units
- 8,401
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)
- 05415067046383/ 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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