Boston Scientific OptiCross Catheter Recall: Decreased Image Brightness Risk
Boston Scientific recalls OptiCross Coronary Imaging Catheters with incorrect voltage settings that may cause decreased image brightness. Affected units include specific lot numbers and UDI/DI codes.
Lower-risk recall
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Contact the company
What happened, in plain English
Boston Scientific is recalling certain Opti:Cross Coronary Imaging Catheters due to a manufacturing issue that may cause decreased image brightness. This could affect medical imaging accuracy during procedures. Read more at govinfonow.com/recall/55986-boston-scientific-opticross-catheter-recall-decreased-image-brightness-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/55986-boston-scientific-opticross-catheter-recall-decreased-image-brightness-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1396-2024
Cite this page
“Boston Scientific OptiCross Catheter Recall: Decreased Image Brightness Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55986-boston-scientific-opticross-catheter-recall-decreased-image-brightness-risk. Based on FDA recall #Z-1396-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1396-2024%22&limit=1).
Why it’s dangerous
The catheters were manufactured with an incorrect voltage setting, which reduces image brightness. This could lead to less accurate imaging during coronary procedures, potentially affecting diagnosis or treatment decisions.
Who’s affected
Healthcare professionals using the recalled catheters for coronary imaging procedures are most at risk. Patients receiving these procedures may also be affected if the catheter is used incorrectly.
How to tell if you have this one
Check for the lot numbers 32426901, 32429407, or 32625286 on the catheter packaging. Also look for the UDI/DI code 08714729938415.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Product Details
Review the lot numbers and UDI/DI code on the catheter packaging to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these catheters?
The recall does not require immediate discontinuation; affected units should be checked for the specific lot numbers and UDI/DI code.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1396-2024 (March 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1396-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.