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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0812 recall (Z-2534-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0815 recall (Z-2535-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0818 recall (Z-2536-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0820 recall (Z-2537-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0840 recall (Z-2538-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0860 recall (Z-2539-2011)Boston Scientific Corporation2011-06-16
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-0880 recall (Z-2540-2011)Boston Scientific Corporation2011-06-16
Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / recall (Z-2418-2011)Boston Scientific Corporation2011-06-10
Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 13 recall (Z-2419-2011)Boston Scientific Corporation2011-06-10
Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in recall (Z-0868-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston Scienti recall (Z-0869-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific Corpora recall (Z-0870-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scienti recall (Z-0871-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Cor recall (Z-0872-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Sci recall (Z-0873-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Cor recall (Z-0874-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Sci recall (Z-0875-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Boston Scientific Corporation: recall (Z-0876-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; Boston Scientific Corporation: recall (Z-0877-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientifi recall (Z-0878-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip; Boston Scientifi recall (Z-0879-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Boston Scientifi recall (Z-0880-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientifi recall (Z-0881-2011)Boston Scientific Corporation2011-01-07
Boston Scientific Guider Softip TM XF Guide Catheter Catheter is intended to facilitate th recall (Z-0885-2011)Boston Scientific Corporation2011-01-07
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 recall (Z-0809-2011)Boston Scientific Corporation2010-12-27
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 recall (Z-0810-2011)Boston Scientific Corporation2010-12-27
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, recall (Z-0811-2011)Boston Scientific Corporation2010-12-27
Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, recall (Z-0812-2011)Boston Scientific Corporation2010-12-27
Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Frem recall (Z-0627-2011)Boston Scientific Corporation2010-12-16
Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific recall (Z-0482-2011)Boston Scientific Corporation2010-11-26
Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Nu recall (Z-0357-2011)Boston Scientific Corporation2010-11-15
Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model N recall (Z-0358-2011)Boston Scientific Corporation2010-11-15
Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston recall (Z-0170-2011)Boston Scientific Corporation2010-11-01
Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) recall (Z-2316-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal Releas recall (Z-2317-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Uncovered Esophageal Stent System - Proximal Release (18/23/7) recall (Z-2318-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/10/7 recall (Z-2319-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9 recall (Z-2320-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/15/1 recall (Z-2321-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/ recall (Z-2322-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Uncovered Large Esophageal Stent System - Distal Release (23/2 recall (Z-2323-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Large Esophageal Stent System - Proximal Release (23/2 recall (Z-2324-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System - Proximal Release (10 recall (Z-2325-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/ recall (Z-2326-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2 recall (Z-2327-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4 recall (Z-2328-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (18/4/2 recall (Z-2329-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (20/6/4 recall (Z-2330-2010)Boston Scientific Corporation2010-08-31
Boston Scientific Ultraflex Precision Colonic Stent System Material/UPN/Catalog Number: M0 recall (Z-2331-2010)Boston Scientific Corporation2010-08-31
FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, recall (Z-197-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, recall (Z-1975-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, recall (Z-1976-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, recall (Z-1977-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, recall (Z-1979-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250, Sterile EO, Boston Scientific, Spencer recall (Z-1980-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO, Boston Scientific, Spencer recall (Z-1981-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-10cm, M00539270, Sterile EO, Boston Scientific, Spence recall (Z-1982-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280, Sterile EO, Boston Scientific, Spence recall (Z-1983-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO, Boston Scientific, Spence recall (Z-1984-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-5cm, M00539300, Sterile EO, Boston Scientific, Spencer, recall (Z-1985-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310, Sterile EO, Boston Scientific, Spencer, recall (Z-1986-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO, Boston Scientific, Spencer recall (Z-1987-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer recall (Z-1988-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340, Sterile EO, Boston Scientific, Spencer recall (Z-1989-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO, Boston Scientific, Spence recall (Z-1990-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-7cm, M00539360, Sterile EO, Boston Scientific, Spence recall (Z-1991-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370, Sterile EO, Boston Scientific, Spenc recall (Z-1992-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO, Boston Scientific, Spenc recall (Z-1993-2010)Boston Scientific Corporation2010-08-25
FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spenc recall (Z-1994-2010)Boston Scientific Corporation2010-08-25
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm recall (Z-2068-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 recall (Z-2069-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm recall (Z-2070-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 recall (Z-2071-2010)Boston Scientific Corporation2010-07-22
Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Singl recall (Z-1817-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog Number: M00568930. Singl recall (Z-1818-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940. Sing recall (Z-1819-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. Sing recall (Z-1820-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960. Sing recall (Z-1821-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. Sing recall (Z-1822-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Sing recall (Z-1823-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/80 Catalog Number: M00569000. Sing recall (Z-1824-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. Sin recall (Z-1825-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. Sin recall (Z-1826-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060. Sin recall (Z-1827-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070. Sing recall (Z-1828-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. Sing recall (Z-1829-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. Sing recall (Z-1830-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230. Sing recall (Z-1831-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240. Sing recall (Z-1832-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250. Sing recall (Z-1833-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Sing recall (Z-1834-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Sing recall (Z-1835-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280. Sing recall (Z-1836-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. Sing recall (Z-1837-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Sing recall (Z-1838-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Sing recall (Z-1839-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410. Sing recall (Z-1840-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430. Sin recall (Z-1841-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450. Sin recall (Z-1842-2010)Boston Scientific Corporation2010-06-25
Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480. Sin recall (Z-1843-2010)Boston Scientific Corporation2010-06-25
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