Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size |
| Product | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140 |
| Quantity | 34 units |
| Distribution | Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally. |
| Initiated | 2013-12-18 |
| Classified | 2014-01-10 |
| Terminated | 2014-08-19 |
| Recall number | Z-0712-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-0712-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67139/
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