Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm… — Class II medical device recall Z-0710-2014
Terminated recall by Boston Scientific Corporation, reported 2014-01-22, distributed nationwide. Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
| Recall number | Z-0710-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2013-12-18 |
| Classified | 2014-01-10 |
| Reported by FDA | 2014-01-22 |
| Terminated | 2014-08-19 |
| Distributed | Nationwide (US) |
| Quantity | 39 units |
| Lot numbers | 16231178 |
Product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
Reason for recall
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0710-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.