Pacemakers: Accolade MRI DR Model L311 recallZ-2749-2016 · Boston Scientific Corporation · initiated Jun 15, 2016
Class II Terminated All recalls posted in September 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.
FDA root cause category: Process control
What the company is doing
As we considered the value of a direct physician communication we have not identified any information that would be of value to the physician because device performance and behavior remain unchanged.
Recall details
- Recall number
- Z-2749-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 15, 2016
- Posted by the FDA
- Sep 7, 2016
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 5
- Product code
- LWP
- FDA submissions
- P150012
- Distribution
- Distributed to the states of TX, NH, MA, PA, and MN.
Product description
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
Code information (models, lots, serial numbers)
serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
Other devices under the same FDA submission
16 devices cleared under P150012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ACCOLADE™ MRI EL DR L331Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls22 deaths7,984 reports
- INGEVITY™ MRI 7741Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes36 deaths7,874 reports
- INGEVITY™+ 7841Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes15 deaths7,419 reports
- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- INGEVITY™+ 7842Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes21 deaths5,995 reports
- INGEVITY™ MRI 7742Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes24 deaths3,967 reports
- INGEVITY™ MRI 7740Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes11 deaths3,257 reports
- INGEVITY™+ 7840Boston Scientific Corporation · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes14 deaths2,640 reports
- ESSENTIO™ MRI DR L111Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls9 deaths1,790 reports
- ACCOLADE™ MRI SR L310Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall10 deaths1,130 reports
- ESSENTIO™ MRI EL DR L131Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls1 death774 reports
- ESSENTIO™ MRI SR L110Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)1 recall2 deaths467 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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