FDA Device recall Z-1999-2021
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
- FDA Device
- Class II
- ongoing
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231 by Boston Scientific, citing 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 de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1999-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-03 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
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.
Identifiers
| code_info | a) L200, Serial Numbers: 464370, 464446, 464458, 464460, 464462, 464468, 464470, 464475, 464481, 464482, 464483, 464490…a) L200, Serial Numbers: 464370, 464446, 464458, 464460, 464462, 464468, 464470, 464475, 464481, 464482, 464483, 464490, 464498, 464500, 464508, 464512, 464516, 464519, 464526, 464528, 464532, 464563, 464590, 705134, 705580, 705587, 705711, 705751, 706215, 708261, 708589, 708797, 708798, 708802, 708815, 708819, 708820, 708832, 708841, 708843, 708844, 708848, 708851, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708907, 708910, 708913, 708914, 708917, 708923, 708928, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708956, 708958, 708963, 708974, 708977, 708981, 708982, 708986, 708987, 709002, 709004, 709006, 709007, 709008, 709013, 709016, 709027, 709033, 709034, 709039, 709042, 709044, 709045, 711776, 711780, 711795, 711804, 711814, 711823, 711839, 711852, 711866, 711868, 711875, 711893, 711894, 711899, 711914, 711917, 711925, 711938, 711947, 711954, 711971, 711997, 712053, 712056, 712084, 712086, 712088, 712093, 712098, 712125, 712129, 712131, |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1999-2021%22
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