FDA Classifies Boston Scientific Imager II Catheter Recall as Class I
FDA classified Boston Scientific's Imager II Angiographic Catheter recall as Class I after reduced stabilizing agents in catheter tips were linked to tip degradation and possible detachment during use.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Boston Scientific is removing specified Imager II Angiographic Catheters after finding that reduced levels of stabilizing agents in the catheter tips may increase the risk of tip degradation and detachment. FDA classified the action as Class I on September 25, 2026. A detached tip may delay a procedure while the catheter is exchanged; although FDA considers embolism remote, a fragment could obstruct blood flow and cause end-organ failure. As of July 16, Boston Scientific had reported two serious injuries and no deaths associated with the issue. The company has decided to discontinue selling the product.
MedTech Current analysis
Why it matters
Catheter-tip detachment during intravascular use can disrupt a procedure and, in a remote worst case, cause a life-threatening embolism. Facilities may store catheters outside their cartons, so the inner-pouch and outer-box UPNs both matter when checking inventory against the affected-device list.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisHealthcare facilitiesCheck the complete FDA product and batch list against inventory, including inner-pouch and outer-box UPN codes, before return.
- MedTech Current analysisClinical teamsMake the recall notice available to staff who use or handle the catheters and continue standard-of-care monitoring for previously treated patients.
- MedTech Current analysisDistributorsIdentify any downstream facilities that received affected product and pass along Boston Scientific's notice.
Official recall information
Official actions
According to FDA and Boston Scientific's customer instructions:
- Immediately stop further use or distribution of affected product and segregate affected inventory.
- Use both inner-pouch and outer-box UPN codes to identify affected product, since the codes differ.
- Use the outer-package product coding on the Reply Verification Tracking Form when reporting products for return.
- Report return quantities as individual catheter units, not cartons, boxes, or five-packs.
- Return affected product and complete and return the Reply Verification Tracking Form.
- Forward the recall notice to relevant personnel and facilities that received affected product.
- Continue the standard of care when monitoring patients previously treated with the product.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Boston Scientific is removing specified Imager II Angiographic Catheters after finding that reduced levels of stabilizing agents in the catheter tips may increase the risk of tip degradation and detachment. FDA classified the action as Class I on September 25, 2026.
If a tip detaches in the vasculature, the procedure may need to pause while the catheter is exchanged. FDA describes embolism from a fragment blocking blood flow as a remote but potentially life-threatening outcome. As of July 16, Boston Scientific had reported two serious injuries and no deaths associated with the issue. The company has decided to discontinue selling the product.
Who and what are affected
The recall covers only the Imager II configurations and batches listed in FDA’s affected-device table. FDA Recall Event ID 99687 has one Class I recall record, Z-3214-2026. FDA lists 262,686 units in commerce and worldwide distribution, including the United States and Puerto Rico. Boston Scientific Corporation is the recalling firm and manufacturer.
The FDA list includes 26 catalog configurations. Facilities may keep catheters in their inner pouches after removing the outer cartons, and the UPN on the inner pouch can differ from the outer-box UPN. Use FDA’s full table to check both codes and the associated batches.
What affected organizations should do
Healthcare facilities and clinical users
According to Boston Scientific’s August 24 customer communication, immediately stop using and distributing affected product, segregate inventory, and return affected catheters. Use both inner-pouch and outer-box UPNs when checking stock. Complete the Reply Verification Tracking Form, reporting the number of individual catheter units rather than cartons or five-packs. Continue standard-of-care monitoring for patients previously treated with the product.
Distributors
Forward the notice to relevant personnel and any facilities that received affected catheters.
MedTech Current analysis
The packaging detail changes how teams should search inventory: checking only the outer carton may miss products stored by inner pouch. Use the FDA affected-device table and Boston Scientific’s return form together to confirm product and batch scope before reporting or returning units.