Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-0368-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ESSENTIO DR Pacemaker

Product Classification:

Class II

Date Initiated: December 7, 2017

Date Posted: January 24, 2018

Recall Number: Z-0368-2018

Event ID: 78787

Reason for Recall:

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

Status: Ongoing

Product Quantity: N/A

Code Information:

Model L101

Distribution Pattern:

AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated