—#151371

Product

Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

FDA product code: LWP — Implantable Pulse Generator, Pacemaker (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P150012
Affected lot / code info: Model 7740 S/N 633464, 610662. Model 7741 S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742 S/N 572200, 584869, 631202. Model 7732 S/N 488740. Model 7736 S/N 631322, 632188.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.

Timeline

Recall initiated: 2016-11-30
Terminated: 2017-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.