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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0286-2021
Related Recalls
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Boston Scientific
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia