Recall Z-1631-2010 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific CRM Corp
Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)
| Date | May 20, 2010 (initiated Sep 10, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.