The Recall Desk
HighFDA (Devices)·Z-1530-2021·Announced 2021-05-19

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.

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 criteria for a High severity score.

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.
Manufacturer
St. Jude Medical, Cardian Rhythm Management Division
Category
Medical Device — Pacemaker
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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

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Same hazard · moisture ingress

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