Recall Z-0579-2020— Boston Scientific Corporation

Name: FDA recall Z-0579-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-24

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2019-10-24, terminated 2023-03-20. It names one FDA 510(k) clearance: K141236. Product: NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EMERGE MR US 3.25MM X 12MM; 9. REF/Catalog No. H7493927612350, NC EMERGE MR OUS 3.50MM X 12MM; 10. REF/Catalog No. H7493926712400, NC EMERGE MR US 4.00MM X 12MM; 11. REF/Catalog No. H7493927612500, NC EMERGE MR OUS 5.00MM X 12MM; 12. REF/Catalog No. H7493927615270, NC EMERGE MR OUS 2.75MM X 15MM; 13. REF/Catalog No. H7493926715300, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.. Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-10-24
Terminated: 2023-03-20
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K141236 — NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corporation·cleared 2014-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EMERGE MR US 3.25MM X 12MM; 9. REF/Catalog No. H7493927612350, NC EMERGE MR OUS 3.50MM X 12MM; 10. REF/Catalog No. H7493926712400, NC EMERGE MR US 4.00MM X 12MM; 11. REF/Catalog No. H7493927612500, NC EMERGE MR OUS 5.00MM X 12MM; 12. REF/Catalog No. H7493927615270, NC EMERGE MR OUS 2.75MM X 15MM; 13. REF/Catalog No. H7493926715300, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.