Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
Boston Scientific is recalling Imager II Angiographic Catheters because the tip may fracture or detach, potentially causing device fragments to remain in or migrate through the patient's vasculature.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the hazard may lead to a 'life-threatening embolism,' which aligns with the rubric criterion for 'significant injury' or risk of serious harm, warranting a score of 4.
Plain-English summary
Boston Scientific Corporation is recalling Imager II Angiographic Catheters under FDA recall number Z-3214-2026. The recall involves 262,686 units distributed worldwide, including the United States, Puerto Rico, and numerous international territories and countries.
The recall was initiated because the catheter tip may fracture or detach. This defect can lead to device fragments remaining within the patient or migrating through the vasculature. The source text notes that patient impact may include a prolonged procedure or a life-threatening embolism.
Healthcare providers and patients should contact Boston Scientific Corporation for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- 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/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 262,686
Distribution
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