Z-2749-2016 Class II Terminated
FDA device recall Z-2749-2016 was initiated by Boston Scientific Corporation on Jun 15, 2016 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Feb 6, 2017). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2016
- Initiation Date
- Jun 15, 2016
- Termination Date
- Feb 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Reason for Recall
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.
Distribution Pattern
Distributed to the states of TX, NH, MA, PA, and MN.
Code Information
serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2749-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026