Z-0180-2010

Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN...

Name: Z-0180-2010 Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN...
Creator: Boston Scientific CRM Corp
Published: 2009-08-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-08-07 / Terminated / root cause: software

FDA source

Boston Scientific CRM Corp began a recall of Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system... on 2009-08-07. The reason FDA records is "The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0180-2010
Status: Terminated
Initiated: 2009-08-07
Posted: 2009-11-12
Terminated: 2012-12-04
Recalling firm: Boston Scientific Corporation
Product: Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientific's servers. It
Root cause tag: software
FDA root cause: Software design
Action: Boston Scientific used phone calls as the delivery method for these communications. The communication began August 6, 2009 for the original 6 patients affected. Notifications via phone calls to additional patients affected began on August 17, 2009. Direct questions about the recall to the LATITUDE Customer Service by calling 1-651-582-4000.
Quantity in commerce: 97
Distribution: Nationwide Distribution -- AZ, AR, CA, CT, FL, GA, IL, IN, MA, MO, NV, NJ, NY, OH, OR, PA, SC, TX, UT, VA and WA.
Product codes and lots: SERIAL NUMBERS: 029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519, 603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067, 055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895, 602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034, 063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973, 063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499, 039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812 024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180.

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)