Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Extraction Balloon Catheter
- Model numbers
- M00547030, M00547000, Instructions for Use: 51878205, Pre-Printed Ouch: 51368417, UDI-DI: 08714729790280, UDI-DI: 08714729790266
- Sizes
- 9-12mm
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
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
Extractor Pro RX Retrieval Balloon Catheter is used in interventional procedures to retrieve devices. The device is a specialized medical tool used by healthcare professionals.
Why This Is Dangerous
Labeling errors can lead to misplacement risks during procedures and misinterpretation of device orientation.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The labeling error could delay procedures or lead to improper device use in clinical settings, potentially affecting patient outcomes.
Practical Guidance
How to identify if yours is affected
- Check model numbers M00547030 and M00547000
- Confirm labeling indicates skive hole above or below the balloon, and verify actual label position
Where to find product info
Find model numbers on the device packaging and IFU documents; UDI-DI on packaging and labeling
What timeline to expect
Refunds or replacements are coordinated through the manufacturer; expect communication via recall notice or letter
If the manufacturer is unresponsive
- Contact FDA consumer complaint portal
- Document all communications and escalation steps
- Seek alternative suppliers through hospital procurement channels
How to prevent similar issues
- Verify device labeling prior to use in procedures
- Cross-check with hospital procurement and device catalogs
- Request updated IFU and labeling during recall
- Maintain proper labeling verification protocols
Documentation advice
Keep all recall notices, communication records, and replacement confirmations; photograph packaging and model numbers
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Product Details
Product: Extractor Pro RX Retrieval Balloon Catheter. UPN REF: M00547030 (9-12mm Below) and M00547000 (9-12mm Above). Distribution: US nationwide in CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA. Quantity: 156 units. Recall date: 2025-08-28. Status: Active.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 156 units recalled nationwide in the US
- M00547030 labeled 9-12mm Below
- M00547000 labeled 9-12mm Above
- Labeling misstatement regarding skive hole position
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Safety Guide
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