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Hurricane RX recallZ-0286-2021 · Boston Scientific Corporation · initiated Sep 16, 2020

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

FDA root cause category: Vendor change control

What the company is doing

All consignees were sent a copy of the customer notification letter via Federal Express Priority Overnight mail on 09/16/2020. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to BSC. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry. The returned products will be quarantined until an appropriate course of action has been determined. BSC will notify FDA of this decision prior to its implementation.

Recall details

Recall number
Z-0286-2021
Status
Open, Classified
Initiated by the company
Sep 16, 2020
Recalling firm
Boston Scientific Corporation
Quantity
15,062 devices distributed in US. 12,930 distributed OUS
Product code
FGE
FDA submissions
K130484
Distribution
Worldwide distribution - US Nationwide and International distribution.

Product description

Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

Hurricane RX Dilation Balloon 4 mm 2 cm UPN/REF # M00545890 GTIN # 08714729283805 Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208 EXP Date Range 04/13/2022 - 06/13/2022  Hurricane RX Dilation Balloon 4 mm 4 cm UPN/REF # M00545900 GTIN # 08714729283812 Lot/Batch #  25326198, 25344165, 25344168, 25366542, 25366543, 25379240, 25379241, 25392546, 25447687, 25447688, 25447689, 25447690, 25447691, 25447692, 25453103, 25453105, 25453108, 25466435, 25468596, 25468597, 25471588, 25479171, 25479176, 25479177, 25479178, 25479521, 25481983, 25481984, 25481985, 25481986, 25497466, 25497467, 25497468, 25506678, 25509440, 25509446, 25509447, 25509450, 25518274, 25518305, 25518314, 25533944, 25536416, 25536680, 25536860, 25543967, 25543969, 25571363, 25575934, 25575935, 25576717, 25576718, 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, 25771765 EXP Date Range 02/07/2022 - 06/27/2022  Hurricane RX Dilation Balloon 6 mm 2 cm UPN/REF # M00545910 GTIN #08714729283829 Lot/Batch # 25456946, 25497472, 25571369, 25623385, 25678822, 25739151 EXP Date Range 03/22/2022 - 06/20/2022  Hurricane RX Dilation Balloon 6 mm 4 cm UPN/REF # M00545920 GTIN # 08714729283836 Lot/Batch # 25305803, 25326193, 25326194, 25326195, 25326199, 25334817, 25334818, 25366544, 25366545, 25366546, 25366547, 25392549, 25392551, 25392553, 25392554, 25392555, 25397943, 25397944, 25447697, 25447698, 25453106, 25453109, 25461680, 25466436, 25468598, 25472425, 25475235, 25475236, 25479172, 25479173, 25479179, 25481987, 25481988, 25481989, 25481990, 25481991, 25497469, 25497470, 25497473, 25497474, 25497475, 25509412, 25509413, 25509414, 25509451, 25509452, 25509453, 25518276, 25518306, 25518307, 25518315, 25518316, 25536681, 25536739, 25536740, 25543970, 25543971, 25543972, 25543973, 25571370, 25571373, 25576770, 25576771, 25576772, 25576773, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773 EXP Date Range 02/02/2022 - 06/27/2022  Hurricane RX Dilation Balloon 8 mm 2 cm UPN/REF # M00545930 GTIN # 08714729283843 Lot/Batch # 25509441, 25536741, 25644951, 25649190, 25650286, 25651334, 25654287 EXP Date Range 04/13/2022 - 05/31/2022  Hurricane RX Dilation Balloon 8 mm 4 cm UPN/REF # M00545940 GTIN # 08714729283850 Lot/Batch # 25317077, 25326196, 25326220, 25326221, 25326222, 25334819, 25344169, 25366548, 25366549, 25392556, 25392557, 25397079, 25447693, 25447694, 25453104, 25453107, 25453110, 25466437, 25468599, 25471589, 25471590, 25475234, 25479174, 25479175, 25479520, 25479580, 25481992, 25497051, 25497052, 25502738, 25509415, 25509416, 25509417, 25509418, 25509419, 25509442, 25509448, 25509454, 25509546, 25518277, 25518278, 25518317, 25518318, 25536682, 25536742, 25536743, 25543975, 25543976, 25543977, 25543978, 25543979, 25544020, 25571371, 25571374, 25596599, 25602458, 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 EXP Date Range 02/04/2022 - 06/30/2022  Hurricane Rx Dilation Balloon 10 mm 2 cm UPN/REF # M00545950 GTIN # 08714729283867 Lot/Batch # 25471587, 25571372, 25588303, 25673064 EXP Date Range 03/28/2022 - 06/06/2022  Hurricane RX Dilation Balloon 10 mm 4 cm UPN/REF # M00545960 GTIN # 08714729283874 Lot/Batch # 25334980, 25344170, 25344171, 25366550, 25378999, 25397945, 25397950, 25447685, 25447695, 25447696, 25461681, 25464817, 25466438, 25471591, 25471592, 25484487, 25493901, 25497471, 25497476, 25509443, 25509444, 25509449, 25518279, 25518308, 25518309, 25536683, 25544022, 25544023, 25544024, 25544025, 25571375, 25602323, 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170 EXP Date 02/08/2022 - 06/20/2022

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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