Boston Scientific Corporation recalls Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;
Boston Scientific recalls specific Imager II Angiographic Catheters models due to risk of tip fracture leading to device fragments remaining in patients or migrating through vasculature, potentially causing life-threatening embolism.
Stop using this now
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
What happened, in plain English
Boston Scientific is recalling certain Imager II Angiographic Catheters models that may fracture or detach during use, leaving fragments inside the patient or causing dangerous migration through blood vessels. This could lead to prolonged procedures or life-threatening embolism. Read more at govinfonow.com/recall/1292563-boston-scientific-imager-ii-angiographic-catheters-recall-tip-fracture-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/1292563-boston-scientific-imager-ii-angiographic-catheters-recall-tip-fracture-risk · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3214-2026
Cite this page
“Boston Scientific Imager II Angiographic Catheters Recall: Tip Fracture Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292563-boston-scientific-imager-ii-angiographic-catheters-recall-tip-fracture-risk. Based on FDA recall #Z-3214-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3214-2026%22&limit=1).
Why it’s dangerous
The catheter tip can fracture or detach during use, causing fragments to remain inside the patient or migrate through blood vessels. This may lead to prolonged procedures or life-threatening embolism where fragments block blood flow.
Who’s affected
Medical professionals using the recalled catheters for angiography procedures are most at risk. Patients who have received these catheters during procedures may also be affected.
How to tell if you have this one
Check for the model numbers listed in the recall: IMAGER II/5/ST/65/038 BX5, IMAGER II/5/ST/100/038 BX5, and other variants with specific batch codes. The product includes a unique device identifier (UDI-DI) and batch numbers listed in the recall.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Stop using it now
Immediately stop using the recalled Imager II Angiographic Catheters if you have them. Do not continue procedures with these models.
Questions people ask
What models are recalled?
The recall includes specific Imager II Angiographic Catheters models with model numbers like IMAGER II/5/ST/65/038 BX5 and IMAGER II/5/ST/100/038 BX5, along with specific batch codes listed in the recall.
What is the risk of using these catheters?
The catheter tip may fracture or detach during use, leading to device fragments remaining inside the patient or migrating through blood vessels, which could cause prolonged procedures or life-threatening embolism.
How do I check if my catheter is recalled?
Check the model number and batch code on your catheter. The recall lists specific model numbers and batch codes (UDI-DI and batch numbers) that you can compare against.
Contact Boston Scientific
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3214-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3214-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-3214-2026 (August 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3214-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.