Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy
Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.
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 a Class II medical device recall involving a risk-of-harm situation—a critical implanted device with potential premature failure. Although no illnesses or injuries have been reported, the hazard is significant enough to warrant regulatory action. The theoretical risk to patients' health justifies a High severity designation.
Plain-English summary
Abbott Medical has recalled the Proclaim 7 Elite Implantable Pulse Generator (REF 3662). The recall affects approximately 30,673 units distributed worldwide, including throughout the United States and numerous other countries.
According to the FDA, the duration between the device reaching the elective replacement indicator threshold and end of service may be shorter than indicated in the product labeling. This means the device may stop functioning sooner than patients and healthcare providers would expect based on product information.
Patients with this device should contact their healthcare provider to discuss this recall. Healthcare providers can determine whether additional monitoring or earlier device replacement is necessary.
The recalled product
- Product
- Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
- Manufacturer
- Abbott Medical
- Affected units
- 30,673
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)
- 05415067020222/ 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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