FDA Expands Recall of Boston Scientific Imager II Catheter Tips
The FDA has expanded its recall of Boston Scientific Imager II catheter tips, urging hospitals to stop use and distribution immediately.
4 reports on this incident · first at Sep 1, 2026, 8:13 a.m. ET
Earlier reports
Sep 1, 2026, 8:53 a.m. ET
FDA Reports Two Serious Injuries in Boston Scientific Imager II Catheter Alert
The U.S. Food and Drug Administration (FDA) has reported two serious injuries and no deaths in connection with the Boston Scientific Imager II catheter tip issue, according to Medical Daily. The agency's alert, which remains ongoing, states that the product may increase the risk that a tip degrades and detaches during use.
The FDA's early alert, as reported by Medical Daily, says the devices were manufactured with reduced levels of stabilizing agents in the tips. The agency has instructed hospitals across the country to immediately stop further use or distribution, segregate affected product, continue standard-of-care monitoring for patients already treated, verify inventory against the list of affected devices, return the product, and complete a verification tracking form.
The cause of the reported injuries has not been determined, and the FDA has not stated a direct link between the injuries and the defect beyond the reported risk.
Sep 1, 2026, 8:23 a.m. ET
FDA Closes Recall Action on Boston Scientific Imager II Catheter Tips
The U.S. Food and Drug Administration has closed its recall action on Boston Scientific's Imager II catheter, according to a report from Medical Daily. The closure means the agency considers the recall carried out, but it repeats the identifying codes for anyone who still has the product.
The recall was issued because the catheter tips were manufactured with reduced levels of stabilizing agents, which may increase the risk that a tip degrades and detaches during use. The FDA reported two serious injuries and no deaths associated with the issue.
The agency's remedy instructed hospitals to immediately stop further use or distribution, segregate affected product, continue standard-of-care monitoring for patients already treated, verify inventory against the list of affected devices, return the product, and complete a verification tracking form. The status of the action is ongoing, according to Medical Daily.
Sep 1, 2026, 8:13 a.m. ETFirst report
FDA Issues Early Alert on Boston Scientific Imager II Catheter Tip
The U.S. Food and Drug Administration (FDA) has issued an early alert regarding Boston Scientific's Imager II catheter, distributed to hospitals across the country. The alert, reported by Medical Daily, states that the device may increase the risk that a tip degrades and detaches during use. The reason cited is that the tips were manufactured with reduced levels of stabilizing agents.
The FDA reports two serious injuries and no deaths associated with the issue. The status of the alert is ongoing. The agency advises healthcare providers to immediately stop further use or distribution, segregate affected product, continue standard-of-care monitoring for patients already treated, verify inventory against the list of affected devices, return the product, and complete a verification tracking form.
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- Version 11 Sept 2026, 13:22current
First published.
- Version 11 Sept 2026, 12:13current
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- Version 11 Sept 2026, 12:53current
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- Version 11 Sept 2026, 12:23current
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