Boston Scientific Corporation: Medical Device Recall in 2020 - (Recall #: Z-1511-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

Product Classification:

Class II

Date Initiated: February 12, 2020

Date Posted: March 25, 2020

Recall Number: Z-1511-2020

Event ID: 85077

Reason for Recall:

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

Status: Terminated

Product Quantity: 4 devices

Code Information:

Serial Numbers: 008885, 010823, 010615, 007886

Distribution Pattern:

US Nationwide distribution in the states of NC, TN, and MO.

Voluntary or Mandated:

Voluntary: Firm initiated