St. Jude Medical Proclaim DRG Implantable Pulse Generator Battery Indicator Recall
St. Jude Medical is recalling 1,744 Proclaim DRG Implantable Pulse Generators because the battery indicator status may be inaccurate.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (inaccurate battery status) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
St. Jude Medical, Inc. is recalling 1,744 Proclaim DRG Implantable Pulse Generator Model 3664 devices. The recall is due to errors in the longevity estimations provided by the Clinician Programmer (CP) or Patient Controller (PC). These errors can cause the battery indicator status to be overestimated or underestimated in certain situations.
The affected devices were distributed worldwide, including nationwide in the United States. The recall includes serial numbers implanted prior to September 12, 2017. A list of foreign consignees will be provided by the firm at a later time.
Patients with these devices should contact their healthcare provider to discuss the potential impact on battery monitoring. The source text does not specify specific consumer actions beyond the general context of a medical device recall.
The recalled product
- Product
- Proclaim DRG Implantable Pulse Generator Model 3664
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 1,744
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 (2)
- Serials implanted prior to September 12
- 2017 are considered part of this advisory
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by St. Jude Medical, Inc. 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.
See all 3 products in this recall →Related recalls
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