FDA Medical Device Recalls (openFDA)
Boston Scientific CRM Corp: 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.
- Recall number
- Z-0180-2010
- Recalling firm
- Boston Scientific CRM Corp
- 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.
- Status
- Terminated
- Initiated
- 2009-08-07
- Posted
- 2009-11-12
- Terminated
- 2012-12-04
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P910077S092"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28