Recall Z-1216-2023 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
| Date | Mar 3, 2023 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| Reason | Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider.. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | The recalling firm issued letters to LATITUDE Healthcare Professionals via third-party Federal Express with signature at the account required on 2/2/2023. The letter informed the HCP that records indicate they may have U.S. patients who do not have HeartLogic enabled as the HCP may have intended in the Model 6460 U.S. LATITUDE NXT Patient Management System. The patients included within the enclosed list are scheduled to have HeartLogic enabled in LATITUDE ON 2/14/2023. The letter provides the clinical impact and recommendations. The recommendations include: (1) Distribute this informatio |
| Quantity | 1,531 patient data records |
| Distribution | US Nationwide distribution to the healthcare facilities and healthcare providers are located in CA, CO, DE, FL, GA, ID, IL, IN, IA, KY, ME, MD, MA, NV, NH, NJ, NY, NC, OH, PA, RI, SC, TN TX, VA, WA, WV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.