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Open, Classified

Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

FDA Recall Z-1998-2021 · Posted 2021-07-02

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeLWP
Date Initiated2021-06-03
Product Quantity31548 units

Reason for Recall

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

Firm Action

The firm began notifying its sales representatives on 06/02/2021 by email or hand delivery and followed with notifying the implanting/following physicians and centers on 06/03/2021 by letter. The letter explained the issue and provided recommendations for the physicians. Information is also posted on www.BostonScientific.com/advisory. Patient notification is done by the implanting/following physician.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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