Recall Z-3260-2018 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product li
| Date | Sep 10, 2018 |
| Status | Terminated |
| Reason | There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. |
| Root cause | Device Design |
| Action | The firm initiated the recall on 09/10/2018 to the US sales representatives by email. The sales representatives were asked to hand deliver the notice to the hospitals when the programmer is retrieved for that location. The sales representatives will electronically confirm the hand delivery of the letter to each affected customer after it occurs. |
| Quantity | 74 units |
| Distribution | Worldwide distribution - US Nationwide in the State of FL, UT, and VA, and countries of Austria, Czech Republic, Germany, Greece, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.