Recalls / —

—#159184

Product

RESONATE EL ICD VR, Model D432, Sterile.

FDA product code

LWS — Implantable Cardioverter Defibrillator (Non-Crt)

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P960040

Affected lot / code info

Serial numbers 224020, 224209, 224322, 224366, and 224506

Why it was recalled

The devices have an incorrect firmware configuration.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.

Recalling firm

Firm

Boston Scientific Corporation

Address

4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern

The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Timeline

Recall initiated

2017-10-04

Terminated

2019-10-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #159184. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.