Emerge Monorail PTCA Dilatation Catheter — Class II medical device recall Z-0577-2020
Terminated recall by Boston Scientific Corporation, reported 2019-12-04, distributed nationwide. Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrop
| Recall number | Z-0577-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2019-10-24 |
| Classified | 2019-11-26 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2023-03-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 14,145 devices |
| UPC / GTIN / UDI-DI | 07493919315250, 08714729799702, 08714729799788, 08714729799894, 08714729799917, 08714729799931, 08714729799993, 08714729800002, 08714729800026, 08714729800040, 08714729800064, 08714729800118, 08714729800132, 08714729800156, 08714729806080, 08714729806103, 08714729806127, 08714729806189, 08714729806196, 08714729806233, 08714729806257 |
| Lot numbers | 20361236, 20452512, 20524227, 20669615, 20909603, 20985435, 21308852, 21309387, 21311605, 21362152, 21363021, 21500615, 222-02-07, 22374160, 22402212, 22416559, 22532219, 22619082, 22734757, 22760617, 22799195, 22909685, 23021557, 23047327, 23181062, 23272475, 23272477, 23324727, 23364688, 23408005, 23518523, 23541254, 23578933, 23881230, 23881291, 23901505, 23924000, 23946181, 23960557, 23975925 and 7 more |
| Model numbers | H7493918912200, H7493918912250, H7493918912300, H7493918915150, H7493918915200, H7493918915300, H7493918915350, H7493919308200, H7493919312200, H7493919312250, H7493919312300, H7493919315150, H7493919315200, H7493919315250, H7493919315300, H7493919315350, H7493919320200, H7493919320250, H7493919320300, H7493919415120 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0577-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.