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Boston Scientific has removed all Imager II Angiographic Catheters from the market after identifying a manufacturing defect that could cause catheter tip degradation and detachment. The FDA classified the action as a Class I recall, its most serious category, and the company has reported two serious injuries and no deaths as of July 16.
Boston Scientific has removed its Imager II Angiographic Catheters from the market after identifying a manufacturing defect affecting the catheter tips, and the FDA has classified the action as a Class I recall — the agency’s most serious category, reserved for devices that may cause serious injury or death. The company has reported two serious injuries and no deaths associated with the issue as of July 16, and has additionally decided to discontinue selling the product entirely.
The affected catheters were manufactured with reduced levels of stabilizing agents in the tips, according to Boston Scientific. The company stated that this deviation may increase the risk of tip degradation and detachment during use. Although the devices were made outside the approved design specification, Boston Scientific noted that no increase in tip detachment complaints has been identified for the affected lots.
On August 24, Boston Scientific sent letters to all affected customers recommending that they immediately stop use and distribution of the devices, segregate affected product, and return it to the company. The letter also instructed facilities to complete and return a Reply Verification Tracking Form (RVTF) verifying by UPN number whether any inventory is affected. The FDA emphasized that inner and outer packaging carry different UPN codes, and that facilities storing product outside its outer carton must check both when searching for affected units.
The FDA first issued an Early Alert communication on August 28, 2026, notifying the public of a potentially high-risk device issue. On September 25, 2026, the agency updated that communication to classify the removal as a Class I recall.
Patient Risk and Clinical Impact
The FDA’s Class I designation means the agency has determined the device may cause serious injury or death if use continues. According to Boston Scientific, the most common adverse consequence of tip detachment is a delay in the procedure to exchange for a new device, with a likelihood of occurring every time the defect manifests. The most serious potential consequence — described by the company as remote — is a life-threatening embolism, in which a detached device fragment obstructs blood flow and causes end organ failure.
The recall also has operational implications for hospitals and clinics. The Imager II catheters are sterile, single-use diagnostic devices used to create images of areas of interest in the peripheral vasculature, meaning facilities performing peripheral vascular imaging must verify inventory, quarantine stock, and arrange replacements. Boston Scientific’s decision to discontinue the product line means affected facilities will need to source alternative catheters going forward.
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How the Recall Unfolded
The timeline, as documented by the FDA, began with Boston Scientific’s customer notification on August 24, recommending removal of all Imager II Angiographic Catheters from use and sale. The FDA followed with an Early Alert on August 28, 2026, its mechanism for notifying the public of potentially high-risk device issues before a formal classification is made.
On September 25, 2026, the FDA updated the communication to formally designate the action a Class I recall, following its standard review process. The agency maintains related records in its FDA Enforcement Report and the CDRH Medical Device Recall Database, and encourages use of Unique Device Identifiers (UDIs) to help facilities accurately identify affected units.
The catheters are sold in 5-packs, and Boston Scientific instructed customers that all reported quantities must represent the actual number of individual units returned, not cartons or multi-packs.
“The most serious potential adverse health consequence within the intravascular space is life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure.”
— Boston Scientific
Open Questions About Affected Lots
The FDA’s public communication does not specify the number of affected lots, manufacturing dates, or total units distributed, referring readers to the product table and the FDA Enforcement Report for device-level details. It is not clear whether additional injuries have been reported since the July 16 figure of two serious injuries. The relationship between the two reported injuries and the specific manufacturing defect — including whether tip detachment was confirmed in those cases — has not been detailed in the public notice.
Boston Scientific’s decision to discontinue the product was announced alongside the recall; the company has not publicly stated whether the discontinuation is permanent or related to broader portfolio considerations.
Steps for Hospitals and Clinicians
Healthcare facilities should verify inventory against the UPN codes on both inner and outer packaging, segregate and return affected product to Boston Scientific, and complete the RVTF. Boston Scientific advised clinicians to continue following the standard of care when monitoring patients previously treated with the device, and to forward the recall notice to any facilities where product was transferred.
Adverse reactions or quality problems can be reported to Boston Scientific at BSCComplaints@bsci.com or to the FDA through its MedWatch program. Further updates, including any expansion of affected lots or revised injury counts, would appear in the FDA’s recall database and Enforcement Report. Because the product line is being discontinued, facilities will need to transition to alternative angiographic catheters for peripheral vascular imaging.
Key Questions
Why are Imager II Angiographic Catheters being recalled?
Boston Scientific stated the catheters were manufactured with reduced levels of stabilizing agents in the tips, which may increase the risk of tip degradation and detachment. The devices were made outside approved design specifications.
Has anyone been injured?
As of July 16, Boston Scientific reported two serious injuries and no deaths associated with the issue. It is not yet clear whether additional reports have emerged since that date.
What should hospitals do with affected devices?
Per the August 24 letter, facilities should immediately stop use and distribution, segregate affected product, verify inventory by UPN number on both inner and outer packaging, complete the Reply Verification Tracking Form, and return product to Boston Scientific.
What is a Class I recall?
It is the FDA’s most serious recall classification, applied when a device may cause serious injury or death if use continues. The FDA classified this recall as Class I on September 25, 2026.
Will the Imager II catheter remain available?
No. Alongside the recall, Boston Scientific has decided to discontinue selling the Imager II Angiographic Catheter. Facilities will need to use alternative devices for peripheral vascular imaging.
Source: primary
