Z-3260-2018Class II

Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System...

Name: Z-3260-2018 Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System...
Creator: Boston Scientific Corporation
Published: 2018-09-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-09-10 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical... on 2018-09-10. FDA classified it as Class II and gives the reason as "There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3260-2018
Classification: Class II
Status: Terminated
Initiated: 2018-09-10
Posted: 2018-09-27
Terminated: 2021-09-22
Recalling firm: Boston Scientific Corporation
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.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated the recall on 09/10/2018 to the US sales representatives by email. The sales representatives were asked to hand deliver the notice to the hospitals when the programmer is retrieved for that location. The sales representatives will electronically confirm the hand delivery of the letter to each affected customer after it occurs.
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3260-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3260-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-27

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)