HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of… — Class II medical device recall Z-0327-2022
Ongoing recall by Boston Scientific Corporation, reported 2021-12-08, distributed nationwide. Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
| Recall number | Z-0327-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-10-21 |
| Classified | 2021-12-01 |
| Reported by FDA | 2021-12-08 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 08714729283874 |
| Lot numbers | 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170, 25806714, 25819946, 25819947, 25819948, 25836147, 25836148, 25850475, 25850476, 25850477, 25850478, 25850479, 25850540, 25850541, 25878986, 25878987, 25878988, 25878989, 25878990, 25878991, 25930854, 25940128 and 199 more |
| Expiration dates | 2022-05-18 |
Product
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
Reason for recall
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
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-0327-2022. 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.