Z-2749-2016Class II

Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These...

Name: Z-2749-2016 Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These...
Creator: Boston Scientific Corporation
Published: 2016-06-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-06-15 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2016-06-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2749-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Posted: 2016-09-07
Terminated: 2017-02-06
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 5
Distribution: Distributed to the states of TX, NH, MA, PA, and MN.
Product codes and lots: serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2749-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2749-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)