Recall Z-0580-2020 ยท MAF Stent, Coronary
Boston Scientific Corporation
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 Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.
| 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
This recall record lists no 510(k) number.