# FDA recall Z-0579-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-10-24.

## 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, N

## 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.

## Distribution

Nationwide including Washington D.C. and Puerto Rico.  OUS to include Canada.

## Key facts

- **Recall number:** Z-0579-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-24
- **Report date:** 2019-12-04
- **Termination date:** 2023-03-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0579-2020

## Citation

> AI Analytics. FDA recall Z-0579-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0579-2020. Source: US FDA. Licensed CC0.

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