St. Jude Medical Recalls Endurity Pacemakers Due to Epoxy Manufacturing Issue
St. Jude Medical is recalling 95,042 Endurity pacemakers because a manufacturing issue with epoxy may allow moisture ingress, potentially causing device malfunction.
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 risk-of-harm product (pacemaker malfunction) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
St. Jude Medical, Cardiac Rhythm Management Division, is recalling 95,042 Endurity pulse generators. These devices are intended to provide single-chamber or dual-chamber bradycardia pacing. The recall affects specific model numbers and serial numbers distributed worldwide, including across the United States and numerous international countries.
The recall is due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemakers from 2015 through 2018. This issue may cause moisture ingress through the device header and feedthrough, which could lead to device malfunction.
Patients with affected devices should contact their healthcare provider or the manufacturer for further instructions. The source text does not specify reported illnesses or injuries associated with this defect.
The recalled product
- Product
- ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
- Category
- Medical Device — Pacemaker
Distribution
Part of a larger recall action
This product is one of 2 recalled by St. Jude Medical, Cardian Rhythm Management Division 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 2 products in this recall →Related recalls
Same manufacturer · St. Jude Medical, Cardian Rhythm Management Division
See all →- HighSt. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress
FDA (Devices) · 2021-05-19
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