Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 5511

FDA device recall Z-1631-2010 · posted 2010-05-20 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

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

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

25,656 (USA), 390 (OUS)

Distribution

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

Date initiated

2009-09-10

Date posted

2010-05-20

Date terminated

2012-04-05

Location

Saint Paul, MN