Model 3300 LATITUDE — Class II medical device recall Z-3260-2018
Terminated recall by Boston Scientific Corporation, reported 2018-10-03, distributed nationwide. There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
| Recall number | Z-3260-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-09-27 |
| Reported by FDA | 2018-10-03 |
| Terminated | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, CZ, DE, ES, GB, GR, NL, NO, PT, SE |
| Quantity | 74 units |
| Serial numbers | 000203, 000224, 000255, 000284, 000434, 000441, 000445, 000488, 000501, 000515, 000519, 000521, 000534, 000536, 000546, 000553, 000578, 000588, 000598, 000601, 000602, 000605, 000606, 000609, 000610 and 49 more |
| Model numbers | 3300 |
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.
Reason for recall
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3260-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.