SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, ST
FDA device recall Z-1374-2019 · posted 2019-05-28 · Terminated
Recall details
- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- 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.
- Action taken
- Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 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.
- Date initiated
- 2019-04-26
- Date posted
- 2019-05-28
- Date terminated
- 2020-09-22
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER (K100819) | Onset Medical Corporation | 2010-08-02 |