FDA Device recall Z-0577-2020
Emerge Monorail PTCA Dilatation Catheter
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of Emerge Monorail PTCA Dilatation Catheter by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0577-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-24 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06…Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06, 3. Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12. 4. Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06. 5. Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18. 6. Lots: 22374160 / 8714729806127 / 2021-03-09, 22532219 / 8714729806127 / 2021-04-16, 22760617 / 8714729806127 / 2021-02-05, 23021557 / 8714729806127 / 2021-01-11, 23181062 / 8714729806127 / 2021-09-10, 23578933 / 8714729806127 / 2021-04-16. 7. Lot: 22799195 / 8714729799931 / 2021-06-12. 8. Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03. 9. Lot: 24088574 / |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0577-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.