Recall Z-2000-2021— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-03
- Firm location
- Saint Paul, MN, United States
Product description
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.