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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. 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.

FDA Recall Z-0577-2020 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLOX
Date Initiated2019-10-24
Date Terminated2023-03-20
Product Quantity14,145 devices total

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.

Firm 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: [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].

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163174Emerge PTCA Dilatation CatheterBoston Scientific Corporation · 2016-12-14K130391EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILATBoston Scientific Corp · 2013-07-10K121196EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corp · 2012-08-31K113220EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)Boston Scientific Corporation · 2012-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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