Boston Scientific Corporation Recall 88991
Description: HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
Boston Scientific Corporation Recall 88991 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0325-2022 |
| Event ID | 88991 |
| Event Description | HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Recall Reason | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure |
| Device Classification | 20211208 |
| Device Code Info | Batches: 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801, 25836093, 25836094, 25836095, 25836096, 25836097, 25836098, 25836099, 25836140, 25836141, 25836142, 25836143, 25836144, 25836145, 25878556, 25894780, 25894781, 25894782, 25916457, 25939485, 25939684, 25940126, 25940127, 25940131, 25947920, 25947921, 25975779, 25975780, 25975781, 25975782, 25975783, 25975784, 25975785, 25975786, 25975787, 26000581, 26000582, 26000583, 26000584, 26051925, 26051926, 26051927, 26058299, 26058420, 26058421, 26058422, 26058425, 26096221, 26096222, 26096223, 26099224, 26123192, 26123193, 26123194, 26123195, 26123196, 26123250, 26123251, 26175474, 26175475, 26175476, 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27269958, 27269959, 27308426, 27308427, 27335095, 27335096, 27335097, 27347594, 27347595, 27347596, 27384709, 27393786, 27407169, 27408779, 27408920, 27408921. GTIN: 08714729283850 Exp. 05/18/2022 to 05/31/2023 |
| Center Classification Date | 20211201 |
| Recall Initiation Date | 20211021 |
| Recalling Firm | Boston Scientific Corporation |
| Similar To |