Recall Z-0938-2017 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific Corporation
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
| Date | Nov 30, 2016 |
| Status | Terminated |
| Reason | Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body. |
| Root cause | Process control |
| Action | Boston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000. |
| Quantity | 15 (2 US; 13 OUS) |
| Distribution | Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.