Recall Z-0577-2020 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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. H
| Date | Oct 24, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 14,145 devices total |
| Distribution | Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113220 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation, Mar 22, 2012 |
| K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corp, Aug 31, 2012 |
| K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT Boston Scientific Corp, Jul 10, 2013 |
| K163174 | Emerge PTCA Dilatation Catheter Boston Scientific Corporation, Dec 14, 2016 |