LATITUDE Patient management System, Model 6488, software… recallZ-1096-2012 · Boston Scientific CRM Corp · initiated Dec 19, 2011
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific CRM Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.
FDA root cause category: Software design
What the company is doing
Beginning on December 19, 2011, for the patients that have attempted to set-up their communicators, Boston Scientific called the patients and their associated LATITUDE clinics to let them know that they can now complete the set-up.
Recall details
- Recall number
- Z-1096-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 19, 2011
- Posted by the FDA
- Feb 23, 2012
- Recalling firm
- Boston Scientific CRM Corp
- Quantity
- 1
- Product code
- LWS
- FDA submissions
- P910077
- Distribution
- Nationwide Distribution, USA - including the states CA, MA, MI, NC, OK, PA, RI, TX, and WA.
Product description
LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code information (models, lots, serial numbers)
Software version 7.2
Other devices under the same FDA submission
34 devices cleared under P910077 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls1 death65 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls9 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls4 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls1 report
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls1 report
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- ZOOM® LATITUDE® 3120Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)4 recalls0 reports
- LATITUDE® Communicator 6290Boston Scientific Corporation · Pacemaker/icd/crt non-implanted components142 reports
- LATITUDE™ Programming System 3300Boston Scientific Corporation · Pacemaker/icd/crt non-implanted components141 reports
- LATITUDE™ Programming System 3300Boston Scientific Corporation · Pacemaker/icd/crt non-implanted components72 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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