Reported Oct 1, 2025 · Ongoing

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

Is this the product you have?

  • Extractor Pro RX Retrieval Balloon Catheter
  • UPN (REF)
    • (1) M00547030 (9-12mm Below)
    • (2) M00547000 (9-12mm Above)
Lot codes and dates

8 of 8 products

Products covered by this recall
#BarcodesProduct as published
151878205
2Pre-Printed Ouch: 51368417
3UPN (REF): M00547030 (9-12mm Below)
408714729790280UDI-DI: 08714729790280
5Lot Numbers: 36398057
6UPN (REF): (1) M00547000(9-12mm Above)
708714729790266UDI-DI: 08714729790266
8Lot Numbers: 36426495
Amount recalled
156 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

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