Reported Dec 4, 2019 · Terminated

NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565

Is this the product you have?

NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes

16 of 16 products

Products covered by this recall
Model / number	Product as published
`H7493926708350`	REF/ , NC EMERGE MR US 3.50MM X 8MM
`H7493927608350`	REF/ , NC EMERGE MR OUS 3.50MM X 8MM
`H7493927608400`	REF/ , NC EMERGE MR OUS 4.00MM X 8MM
`H7493927612200`	REF/ , NC EMERGE MR OUS 2.00MM X 12MM
`H7493926712250`	REF/ , NC EMERGE MR US 2.50MM X 12MM
`H7493927612250`	REF/ , NC EMERGE MR OUS 2.50MM X 12MM
`H7493926712270`	REF/ , NC EMERGE MR US 2.75MM X 12MM
`H7493926712320`	REF/ , NC EMERGE MR US 3.25MM X 12MM
`H7493927612350`	REF/ , NC EMERGE MR OUS 3.50MM X 12MM
`H7493926712400`	REF/ , NC EMERGE MR US 4.00MM X 12MM
`H7493927612500`	REF/ , NC EMERGE MR OUS 5.00MM X 12MM
`H7493927615270`	REF/ , NC EMERGE MR OUS 2.75MM X 15MM
`H7493926715300`	REF/ , NC EMERGE MR US 3.00MM X 15MM
`H7493927615300`	REF/ , NC EMERGE MR OUS 3.00MM X 15MM
`H7493927615320`	REF/ , NC EMERGE MR OUS 3.25MM X 15MM
`H7493926715350`	REF/ , NC EMERGE MR US 3.50MM X 15MM.

Lot codes and dates: 16 of 16 products
Products covered by this recall
# Barcodes Product as published
1 8714729846284 21333639 / 8714729846284 / 2019-11-03.
2 8714729847007 23808016 / 8714729847007 / 2021-05-16.
3 8714729847021 21865055 / 8714729847021 / 2020-03-14.
4 8714729847076 24119885 / 8714729847076 / 2021-07-16.
5 8714729846376 23541260 / 8714729846376 / 2021-03-25.
6 8714729847090 22119751 / 8714729847090 / 2020-05-14.
7 8714729846383 22294873 / 8714729846383 / 2020-06-24.
8 8714729846406 24119876 / 8714729846406 / 2021-07-21.
9 871472984713787147298471378714729847137 23479019 /8714729847137 / 2021-03-12 , 23874443 / 8714729847137 / 2021-05-29, 24133485 / 8714729847137 / 2021-07-18.
10 8714729846437 23998680 / 8714729846437 / 2021-06-23.
11 8714729847175 22690879 / 8714729847175 / 2020-09-21.
12 87147298472368714729847236 23511693 / 8714729847236 / 2021-03-19, 23584725 / 8714729847236 / 2021-04-02.
13 8714729846529 21327739 / 8714729846529 / 2019-11-02.
14 87147298472438714729847243 23436304 / 8714729847243 / 2021-03-04, 23541268 / 8714729847243 / 2021-03-25.
15 8714729847250 23931831 / 8714729847250 / 2021-06-10.
16 8714729846543 23998683 / 8714729846543 / 2021-06-21.
Amount recalled: 14,145 devices total

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

Nationwide
PR
WA

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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135 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`8714729846284`	21333639 / 8714729846284 / 2019-11-03.
2	`8714729847007`	23808016 / 8714729847007 / 2021-05-16.
3	`8714729847021`	21865055 / 8714729847021 / 2020-03-14.
4	`8714729847076`	24119885 / 8714729847076 / 2021-07-16.
5	`8714729846376`	23541260 / 8714729846376 / 2021-03-25.
6	`8714729847090`	22119751 / 8714729847090 / 2020-05-14.
7	`8714729846383`	22294873 / 8714729846383 / 2020-06-24.
8	`8714729846406`	24119876 / 8714729846406 / 2021-07-21.
9	`871472984713787147298471378714729847137`	23479019 /8714729847137 / 2021-03-12 , 23874443 / 8714729847137 / 2021-05-29, 24133485 / 8714729847137 / 2021-07-18.
10	`8714729846437`	23998680 / 8714729846437 / 2021-06-23.
11	`8714729847175`	22690879 / 8714729847175 / 2020-09-21.
12	`87147298472368714729847236`	23511693 / 8714729847236 / 2021-03-19, 23584725 / 8714729847236 / 2021-04-02.
13	`8714729846529`	21327739 / 8714729846529 / 2019-11-02.
14	`87147298472438714729847243`	23436304 / 8714729847243 / 2021-03-04, 23541268 / 8714729847243 / 2021-03-25.
15	`8714729847250`	23931831 / 8714729847250 / 2021-06-10.
16	`8714729846543`	23998683 / 8714729846543 / 2021-06-21.