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 dilat
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling its Hurricane RX Biliary Balloon Dilatation Catheter devices due to a defect where the RX tunnel component (black sheath) may detach from the catheter shaft because of lower bond strength. The recall affects approximately 15,062 devices distributed in the United States and 12,930 devices distributed outside the United States. The affected devices include multiple catalog reference numbers (M00545890, M00545900, M00545910, M00545920, M00545930, M00545940, M00545950, M00545960) with various lot/batch numbers and expiration date ranges primarily between February 2022 and June 2022.
The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
Reason for recall: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. Distribution: Worldwide distribution - US Nationwide and International distribution. Quantity: 15,062 devices distributed in US. 12,930 distributed OUS Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.