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 # Barcodes Product as published 1 51878205 2 Pre-Printed Ouch: 51368417 3 UPN (REF): M00547030 (9-12mm Below) 4 08714729790280UDI-DI: 08714729790280 5 Lot Numbers: 36398057 6 UPN (REF): (1) M00547000(9-12mm Above) 7 08714729790266UDI-DI: 08714729790266 8 Lot 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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