Boston Scientific pulls all Imager II catheters after tip-manufacturing defect
Rule ChangesTwo serious injuries reported; company discontinues the product line rather than fix the issue
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Overview
Updated 2 hours agoBoston Scientific told hospitals to stop using every Imager II Angiographic Catheter it has sold. The tips were made with too little stabilizing agent, which raises the risk they could degrade and detach inside a patient's blood vessel.
Two patients have been seriously injured as of July 16. The company chose to discontinue the product entirely rather than correct the manufacturing problem, and the Food and Drug Administration (FDA) posted an Early Alert in early September 2026.
Why it matters
If a catheter tip detaches in a patient's artery, the fragment can block blood flow and trigger a life-threatening embolism — and every Imager II unit ever sold is now being pulled from shelves.
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People Involved
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A major medical-device maker headquartered in Marlborough, Massachusetts.
The federal agency that regulates medical devices and oversees recalls.
Timeline
July 2026 September 2026
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Recall becomes public news
Today Media ReportTrade and business outlets report that Boston Scientific halted sales of the catheters.
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FDA issues Early Alert
RegulatoryFDA publicizes the potentially high-risk device issue and Boston Scientific's removal decision.
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Boston Scientific sends recall letter
Recall ActionCompany tells customers to stop using and distributing all Imager II catheters, verify inventory by UPN, and return product.
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Two serious injuries on record
Safety DataBoston Scientific reports two serious injuries tied to the tip issue; no deaths.
Historical Context
2 moments from history that rhyme with this story — and how they unfolded.
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.
Silk Road Medical catheter removal (2026)
Earlier in the same year, Boston Scientific removed another catheter from the market over a tip-separation risk. That product was part of a stroke-prevention system made by Silk Road Medical, which Boston Scientific acquired in 2024.
The device was pulled shortly after the acquisition, raising questions about the acquired product line's quality controls.
Two tip-related removals in one year pressure Boston Scientific's quality-management reputation.
It shows 2026 was a difficult year for Boston Scientific's catheter quality, with two separate products removed for tip-integrity failures.
