| | Class 2 Device Recall Emerge OverTheWire and Emerge Monorail PTCA Dilatation Catheters |  |
| Date Initiated by Firm | October 24, 2019 |
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| Create Date | November 26, 2019 |
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| Recall Status1 |
Terminated 3 on March 20, 2023 |
| Recall Number | Z-0577-2020 |
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| Recall Event ID |
84152 |
| 510(K)Number | K113220 K121196 K130391 K163174 |
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| Product Classification |
Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
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| 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. |
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| Code Information |
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. |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 14,145 devices total |
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| Distribution | Nationwide including Washington D.C. and Puerto Rico.
OUS to include Canada. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = LOX
510(K)s with Product Code = LOX
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