FDA Device recall Z-3257-2018
ACCOLADE Pacemaker
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of ACCOLADE Pacemaker by Boston Scientific, citing boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated bat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3257-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-10 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WI, WV, WY |
Product
ACCOLADE Pacemaker
Reason
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Identifiers
| code_info | ACCOLADE SR model L300, ACCOLADE DR model L301, ACCOLADE MRI SR model L310, ACCOLADE MRI DR model L311, ACCOLADE EL DR…ACCOLADE SR model L300, ACCOLADE DR model L301, ACCOLADE MRI SR model L310, ACCOLADE MRI DR model L311, ACCOLADE EL DR model L321 and ACCOLADE MRI EL DR model L331. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3257-2018%22
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