FDA Device recall Z-0710-2014
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon C…
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon C… by Boston Scientific, citing extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0710-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-18 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Identifiers
| code_info | Lot Number:16231178 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.