St. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators
St. Jude Medical is recalling 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.
What this means for you
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 involves a Class II medical device with a risk of harm (inaccurate battery status) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
St. Jude Medical, Inc. is recalling 28,817 units of the Proclaim 5 Elite and Proclaim 7 Elite Implantable Pulse Generators (Models 3660, 3661, 3662, 3663, 3665, and 3667). The devices were distributed worldwide, including nationwide 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 serial numbers are listed in the source document, including those implanted prior to September 12, 2017. Patients with these devices should contact their healthcare provider for further evaluation and management of the battery status.
The recalled product
- Product
- Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
- Manufacturer
- St. Jude Medical, Inc.
- Hazard
- Affected units
- 28,817
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
Same manufacturer · St. Jude Medical, Inc.
See all →- HighSt Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
FDA (Devices) · 2019-08-14
- SevereSt Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures
FDA (Devices) · 2019-08-14
Same hazard · battery indicator error
See all →- HighSt. Jude Medical Recalls Infinity 5 and 7 Implantable Pulse Generators
FDA (Devices) · 2017-10-25