Boston Scientific is recalling approximately 57,312 Guider Softip XF Guide Catheters because certain lots have the incorrect tip curve shape. The catheters were manufactured with a tip shape that does not match the product label, which can lead to difficulties or complications during cardiac procedures. These devices were distributed across Indiana and nationwide between the dates indicated in the affected lot list.
If a surgeon uses a catheter with an incorrect tip shape, it may not navigate the patient's anatomy as intended, potentially causing vessel injury, procedure delays, or ineffective treatment. No specific injuries have been reported in the provided data, but the mismatch between the labeled and actual product shape poses a surgical risk.
Quarantine and return product to manufacturer.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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