Quick Facts at a Glance
- Recall Date
- December 3, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Product type
- Balloon Dilation Catheter
- Model numbers
- 1) GTIN 08714729796527, Batch Number 37370117, exp. 3-Sept-28, 2) GTIN 08714729796756, Batch Number 37416646, exp. 9-Sept-28
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 3, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
The Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheter is used in medical procedures to dilate blood vessels. Healthcare providers typically use these devices for angioplasty to treat narrowed or blocked blood vessels.
Why This Is Dangerous
The defect in the manufacturing process can lead to difficulties in inflating or deflating the catheter. This can hinder the intended medical procedure and pose significant risks to patient health.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on these devices for medical treatment face serious risks if they continue to use the recalled catheters. Immediate action is required to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the catheter packaging or device.
- Verify if the device was manufactured between September 12, 2025, and October 13, 2025.
- Contact Boston Scientific for confirmation if unsure.
Where to find product info
Look for the model number and manufacturing date on the catheter packaging or the product itself, typically located on the labels.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements once the return is initiated.
If the manufacturer is unresponsive
- Document your communication attempts with Boston Scientific.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Ensure devices have current safety certifications before purchase.
- Verify the manufacturing dates and recall history on medical devices.
- Consult with healthcare providers about the safest options available.
Documentation advice
Keep records of all communications regarding the recall, including receipts and photos of the device.
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Product Details
The recall involves Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters, specifically models REF H74939186251210 and REF H74939186351210. These were distributed nationwide across multiple states including MA, WV, OH, CA, MN, NY, VA, IL, TX, and FL. The devices were manufactured between September 12, 2025, and October 13, 2025.
Key Facts
- Recall date: December 3, 2025
- Active recall status
- Manufactured from September 12, 2025 to October 13, 2025
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Safety Guide
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