Z-3260-2018 Class II Terminated
FDA device recall Z-3260-2018 was initiated by Boston Scientific Corporation on Sep 10, 2018 and is designated Class II. Reason for recall: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. The recall status is terminated (terminated Sep 22, 2021). Affected quantity: 74 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 10, 2018
- Termination Date
- Sep 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
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.
Distribution Pattern
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
Code Information
Serial Numbers: 001343 000488 000903 001404 000923 001352 001441 000203 000224 000255 000284 000434 000441 000445 000501 000515 000519 000521 000534 000536 000546 000553 000578 000588 000601 000602 000605 000606 000609 000610 000616 000617 000620 000628 000631 000633 000634 000636 000637 000638 000643 000644 000661 000664 000666 000667 000669 000671 000673 000677 000679 000682 000688 000690 000691 000700 000710 000717 000719 000720 000723 000726 000746 000757 000765 000924 001125 001556 001562 001564 001571 001574 001615 000598
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3260-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026