Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. |
| Product | Model 3300 LATITUDE(TM) Programming System 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. |
| Quantity | 74 units |
| Distribution | Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland |
| Initiated | 2018-09-10 |
| Classified | 2018-09-27 |
| Terminated | 2021-09-22 |
| Recall number | Z-3260-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-3260-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81006/
Alerts for Boston Scientific Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.