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Terminated

Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)

FDA Recall Z-1631-2010 · Posted 2010-05-20

Recalling FirmBoston Scientific CRM Corp
Recall StatusTerminated
Product CodeLWS
Date Initiated2009-09-10
Date Terminated2012-04-05
Product Quantity25,656 (USA), 390 (OUS)

Reason for Recall

Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test will not be displayed for physician review

Firm Action

Consignees were sent on 9/10/09 a Boston Scientific "Urgent Medical Device Information" letter dated September 9, 2009. The letter was addressed to "Dear Doctor". The letter provided the information related to the LATITUDE Patient Management system recall as to Background, Description, Rate of Occurrence, Patient management, Devices Affected and Further Information. Patients were also sent a Boston Scientific letter dated September 9, 2009. The letter addressed Background information, Why are we communicating, What You Should Do and Questions.

Root Cause

Software design

Distribution Pattern

All States in the US including Puerto Rico United Kingdom, Switzerland, Netherlands, Italy, Germany, France, Finland, Denmark, Belgium, Austria

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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