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Boston Scientific Corporation recalls Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Cat
Recalled December 4, 2019 · FDA recall Z-0577-2020 · Boston Scientific
Hazard
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. · FDA Class II
Units
14,145 devices total
Sold at
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Description
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Product
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; 9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; 10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, 11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; 12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; 13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; 15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; 16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; 17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; 18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; 19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; 20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →