St. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress
St. Jude Medical is recalling Assurity and Endurity pacemakers because a manufacturing issue with epoxy mixing may allow moisture to enter the device, potentially causing malfunction.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and…"
Plain-English summary
St. Jude Medical, Cardian Rhythm Management Division, is recalling Assurity and Endurity pacemakers. The recall involves 242,945 units distributed worldwide, including nationwide distribution in the United States and in numerous other 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 the devices to malfunction due to moisture ingress through the device header and feedthrough.
Affected devices include specific model numbers and serial numbers listed in the official recall documentation. Patients with these devices should contact their healthcare provider for evaluation and potential replacement.
The recalled product
- Product
- ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL 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 →- SevereSt. Jude Medical Recalls Endurity Pacemakers Due to Epoxy Manufacturing Issue
FDA (Devices) · 2021-05-19
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