Boston Scientific Corporation: 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.

Recall number

Z-0577-2020

Recalling firm

Boston Scientific Corporation

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.

Status

Terminated

Initiated

2019-10-24

Posted

not on file

Terminated

2023-03-20

Reason

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.

Root cause

Process control

Action

The firm, Boston Scientific, sent an "Urgent Medical Device Removal" letter dated 10/28/2019 overnight mail delivery to its customers. The letter stated the issue, identified affected product and stated that product should not be used. The customers were instructed, if any product is identified to segregate immediately and return to Boston Scientific. The customers were also instructed to Immediately complete the RECALL REMOVAL REPLY VERIFICATION TRACKING FORM and Scan/e-mail to: BSCFieldActionCenter@bsci.com OR Fax to #: 1-866-213-1806. This form must be completed and returned in all cases even if you do not have any affected product. If you are a distributor, please note that the removal notification should be forwarded to your customers. If you have any questions, contact Boston Scientific Quality Systems at 763-494-1133 or email: BSCFieldActionCenter@bsci.com.

Quantity

14,145 devices total

Distribution

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

Lot, serial or model codes

Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2. Lot: 21362152 / 8714729806080 / 2020-07-06, 3. Lots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12.  4. Lots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06.  5. Lots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18.  6. 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. Lot: 22799195 / 8714729799931 / 2021-06-12.  8. Lots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03.  9. Lot: 24088574 / 8714729799993 / 2022-03-07.  10. Lots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19.  11. Lots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15.  12. 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. Lot: 23924000 / 8714729806233 / 2022-02-04.  14. Lots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20.  15. Lot: 23901505 / 8714729806257 / 2022-01-30.  16. Lot: 24133473 / 8714729800064 / 2022-03-15.  17. Lots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08.  18. Lots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24.  19. Lots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15.  20. Lot: 23364688 / 8714729799702 / 2021-10-16.

510(k) numbers

["K113220","K121196","K130391","K163174"]

PMA numbers

not on file

Product code

LOX

Firm FEI

3002095335

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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