Recall Z-1375-2019 ยท DYB Introducer, Catheter
Terumo Medical Corporation
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
| 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 | 1431 |
| 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
| K152498 | SoloPath Re-Collapsible Access System Onset Medical Corporation, Jan 5, 2016 |