Recall Z-0114-2017 ยท KRA Catheter, Continuous Flush
Sequent Medical Inc
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into
| Date | Oct 27, 2016 (initiated Sep 23, 2016) |
| Status | Terminated |
| Reason | Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. |
| Root cause | Under Investigation by firm |
| Action | Sequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to www.customerserviceus@sequentmedical.com. Customers with questions should call (949) 830-9600x130. For questions regarding this recall call 9 |
| Quantity | 618 units |
| Distribution | Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132652 | VIA MICROCATHETER, VIA PLUS MICROCATHETER Sequent Medical, Inc., Dec 20, 2013 |