FDA Device recall Z-0321-2022
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi
- FDA Device
- Class II
- ongoing
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi by Boston Scientific, citing balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0321-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-21 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Reason
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Identifiers
| code_info | GTIN: 08714729283812 Lot Numbers: 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612…GTIN: 08714729283812 Lot Numbers: 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771763, 25771764, 25771765, 25771766, 25771767, 25771768, 25771769, 25771770, 25771771, 25836081, 25836082, 25878553, 25878554, 25878555, 25894783, 25916270, 25916271, 25916445, 25916446, 25940122, 25940123, 25947675, 25947677, 25947678, 25947900, 25947902, 25947904, 25947905, 25975766, 25975767, 25975768, 25975769, 25975770, 25975771, 25975772, 25975773, 26000472, 26000473, 26000474, 26000475, 26000696, 26000697, 26000698, 26000699, 26010388, 26010389, 26010390, 26010391, 26058285, 26058286, 26087174, 26087175, 26087176, 26087177, 26087178, 26087179, 260877 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0321-2022%22
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