FDA Device recall Z-2673-2017
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300 by Boston Scientific, citing label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be ab….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2673-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-01 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | MI, MO |
Product
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Reason
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
Identifiers
| code_info | Lot Number: 19343203 Exp.: 6/30/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2673-2017%22
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