Boston Scientific LATITUDE Patient Management System… recallZ-1445-2012 · Boston Scientific CRM Corp · initiated Feb 24, 2012
Terminated All recalls posted in April 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 LATITUDE Patient Management System Communicators were shipped to the incorrect patients.
FDA root cause category: Process control
What the company is doing
The patients were notified via phone starting on 2/24/12 that their communicator will not be able to activate successfully and that their communicator and sensors will be replaced. If the patient could not be reached via phone or voice mail, a Boston Scientific letter dated 2/29/12 was sent to the patient. The letter described the problem, explained What is a LATITUDE Communicator and What should you do. Questions were directed to Patient Services at (866) 484-3268.
Recall details
- Recall number
- Z-1445-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 24, 2012
- Posted by the FDA
- Apr 20, 2012
- Recalling firm
- Boston Scientific CRM Corp
- Quantity
- 8
- Product code
- LWS
- FDA submissions
- P910077
- Distribution
- Nationwide Distribution, including the states of: AL, CA, FL, IL, IN, MO, NJ, NY, OH, OR, TX VA, and WA.
Product description
Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. 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.
Code information (models, lots, serial numbers)
219329 218900 219316 219304 219367 219372 218958 218842
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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