Agency classClass IOur severity:Severe FDA (Devices)·Z-1531-2021·Announced 2021-05-19

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.

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, 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.
Manufacturer: St. Jude Medical, Cardian Rhythm Management Division
Category: Medical Device — Pacemaker
Hazard: device-malfunction
moisture-ingress

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 →

Same manufacturer · St. Jude Medical, Cardian Rhythm Management Division

See all →

Severe
St. Jude Medical Recalls Assurity and Endurity Pacemakers Due to Moisture Ingress
FDA (Devices) · 2021-05-19

Same hazard · device malfunction