Minnesota — TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · device

Boston Scientific Corporation — Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/0

Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Maple Grove, MN, US · Updated 9/23/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

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