Reported Oct 3, 2018 · Terminated
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N Bldg 3 · Saint Paul, MN · 55112-5700
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
74 of 74 codes
001343000488000903001404000923001352001441000203000224000255000284000434000441000445000501000515000519000521000534000536000546000553000578000588000601000602000605000606000609000610000616000617000620000628000631000633000634000636000637000638000643000644000661000664000666000667000669000671000673000677000679000682000688000690000691000700000710000717000719000720
- Serial Numbers
- Amount recalled
- 74 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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