Recall Z-1374-2019 ยท DYB Introducer, Catheter
Terumo Medical Corporation
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Bot
| Date | May 28, 2019 (initiated Apr 26, 2019) |
| Status | Terminated |
| Reason | There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. |
| Root cause | Device Design |
| Action | Urgent Medical Device Recall letters dated 4/26/19 were sent to customers. |
| Quantity | 2228 |
| Distribution | The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER Onset Medical Corporation, Aug 2, 2010 |