Imager II recall (2020)
Boston Scientific recalled 6,130 Imager II 5F Angiographic Catheters distributed between July 2018 and November 2019 after nine people were injured by a faulty catheter tip. The tips could detach during a procedure or during procedure preparation.
The FDA flagged risks of additional surgery to remove the detached tip, embolism, stroke, or death.
The 2020 recall established a pattern: this product family had tip-integrity problems years before the 2026 removal.
The same catheter family is now the subject of a market-wide removal, showing a recurring manufacturing vulnerability rather than an isolated batch defect.
