St. Jude Medical Recalls Infinity 5 and 7 Implantable Pulse Generators
St. Jude Medical is recalling 3,119 Infinity 5 and 7 Implantable Pulse Generators because battery longevity estimations 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, and the hazard involves a risk-of-harm product (implantable medical device) where the specific injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
St. Jude Medical, Inc. is recalling 3,119 units of the Infinity 5 and Infinity 7 Implantable Pulse Generators (Models 6660, 6661, 6662, and 6663). The recall involves devices distributed worldwide, including nationwide distribution in the United States.
The recall was initiated because analysis revealed errors in the battery 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.
Affected devices are those implanted prior to September 12, 2017, with specific serial numbers listed in the recall documentation. Patients with these devices should contact their healthcare provider to discuss the recall and determine the appropriate course of action.
The recalled product
- Product
- Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
- Manufacturer
- St. Jude Medical, Inc.
- Hazard
- Affected units
- 3,119
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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