FDA-Device2021-07-14Class II
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Hazard
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.
Sold states
Worldwide distribution.
Affected count
31548 units
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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