# FDA recall Z-0577-2020

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

## 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 15M

## 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-0577-2020
- **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-0577-2020

## Citation

> AI Analytics. FDA recall Z-0577-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0577-2020. Source: US FDA. Licensed CC0.

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