Boston Scientific Corporation: Medical Device Recall in 2016 - (Recall #: Z-2749-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 15, 2016

Date Posted: September 14, 2016

Recall Number: Z-2749-2016

Event ID: 74812

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.

Status: Terminated

Product Quantity: 5

Code Information:

serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.

Distribution Pattern:

Distributed to the states of TX, NH, MA, PA, and MN.

Voluntary or Mandated:

Voluntary: Firm initiated