NC Emerge recallZ-0579-2020 · Boston Scientific Corporation · initiated Oct 24, 2019

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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: [email protected] 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: [email protected].

Recall details

Recall number: Z-0579-2020
Status: Terminated
Initiated by the company: Oct 24, 2019
Recalling firm: Boston Scientific Corporation
Quantity: 14,145 devices total
Product code: LOX
FDA submissions: K141236
Distribution: Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.

Product description

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, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

NC Emerge® H7493926712250
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall33 reports
NC Emerge® H7493926715300
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall32 reports
NC Emerge® H7493926715350
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall17 reports
NC Emerge® H7493926712400
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall11 reports
NC Emerge® H7493926712320
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall8 reports
NC Emerge® H7493926712270
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall7 reports
NC Emerge® H7493926708350
Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous
1 recall3 reports

Product lines

NC EmergeBoston Scientific Corporation · 61 models · 456 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 84152).

Z-0577-2020 · Terminated
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. …
Z-0578-2020 · Terminated
Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070…
Z-0580-2020 · Terminated
Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chro…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page