Reported Dec 4, 2019 · Terminated

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?

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

20 of 20 products

Products covered by this recall
Model / number	Product as published
`H7493919308200`	REF/ EMERGE MR, OUS 2.00mm X 8mm
`H7493918912200`	REF/ , EMERGE MR US 2.00MM X 12MM
`H7493919312200`	REF/ , EMERGE MR, OUS 2.00mm X 12mm
`H7493918912250`	REF/ , EMERGE MR US 2.50MM X 12MM
`H7493919312250`	REF/ , EMERGE MR, OUS 2.50mm X 12mm
`H7493918912300`	REF/ , EMERGE MR US 3.00MM X 12MM
`H7493919312300`	REF/ , EMERGE MR, OUS 3.00mm X 12mm
`H7493918915150`	REF/ , EMERGE MR US 1.50MM X 15MM
`H7493919315150`	REF/ , EMERGE MR, OUS 1.50mm X 15mm
`H7493918915200`	REF/ , EMERGE MR US 2.00MM X 15MM
`H7493919315200`	REF/ , EMERGE MR, OUS 2.00mm X 15mm
`H7493919315250`	REF/ , EMERGE MR, OUS 2.50mm X 15mm
`H7493918915300`	REF/ , EMERGE MR US 3.00MM X 15MM
`H7493919315300`	REF/ , EMERGE MR, OUS 3.00mm X 15mm
`H7493918915350`	REF/ , EMERGE MR US 3.50MM X 15MM
`H7493919315350`	REF/ , EMERGE MR, OUS 3.50mm X 15mm
`H7493919320200`	REF/ , EMERGE MR, OUS 2.00mm X 20mm
`H7493919320250`	REF/ , EMERGE MR, OUS 2.50mm X 20mm
`H7493919320300`	REF/ , EMERGE MR, OUS 3.00mm X 20mm
`H7493919415120`	REF/ , EMERGE PUSH MR, OUS 1.20mm X 15mm.

Lot codes and dates: 20 of 20 products
Products covered by this recall
# Barcodes Product as published
1 8714729799788 24112923 / 8714729799788 / 2022-03-12
2 8714729806080 Lot: 21362152 / 8714729806080 / 2020-07-06
3 8714729799894871472979989487147297998948714729799894 Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12.
4 871472980610387147298061038714729806103 Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06.
5 8714729799917871472979991787147297999178714729799917 Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18.
6 871472980612787147298061278714729806127871472980612787147298061278714729806127 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 8714729799931 Lot: 22799195 / 8714729799931 / 2021-06-12.
8 87147298061898714729806189 Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03.
9 8714729799993 Lot: 24088574 / 8714729799993 / 2022-03-07.
10 87147298061968714729806196 Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19.
11 8714729800002871472980000287147298000028714729800002 Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15.
12 87147298000268714729800026871472980002687147298000268714729800026 Lots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19.
13 8714729806233 Lot: 23924000 / 8714729806233 / 2022-02-04.
14 87147298000408714729800040 Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20.
15 8714729806257 Lot: 23901505 / 8714729806257 / 2022-01-30.
16 8714729800064 Lot: 24133473 / 8714729800064 / 2022-03-15.
17 87147298001188714729800118 Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08.
18 871472980013287147298001328714729800132 Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24.
19 87147298001568714729800156 Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15.
20 8714729799702 Lot: 23364688 / 8714729799702 / 2021-10-16.
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	`8714729799788`	24112923 / 8714729799788 / 2022-03-12
2	`8714729806080`	Lot: 21362152 / 8714729806080 / 2020-07-06
3	`8714729799894871472979989487147297998948714729799894`	Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12.
4	`871472980610387147298061038714729806103`	Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06.
5	`8714729799917871472979991787147297999178714729799917`	Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18.
6	`871472980612787147298061278714729806127871472980612787147298061278714729806127`	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	`8714729799931`	Lot: 22799195 / 8714729799931 / 2021-06-12.
8	`87147298061898714729806189`	Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03.
9	`8714729799993`	Lot: 24088574 / 8714729799993 / 2022-03-07.
10	`87147298061968714729806196`	Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19.
11	`8714729800002871472980000287147298000028714729800002`	Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15.
12	`87147298000268714729800026871472980002687147298000268714729800026`	Lots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19.
13	`8714729806233`	Lot: 23924000 / 8714729806233 / 2022-02-04.
14	`87147298000408714729800040`	Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20.
15	`8714729806257`	Lot: 23901505 / 8714729806257 / 2022-01-30.
16	`8714729800064`	Lot: 24133473 / 8714729800064 / 2022-03-15.
17	`87147298001188714729800118`	Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08.
18	`871472980013287147298001328714729800132`	Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24.
19	`87147298001568714729800156`	Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15.
20	`8714729799702`	Lot: 23364688 / 8714729799702 / 2021-10-16.