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U.S. Department of Health and Human Services

Class 1 Device Recall SOLOPATH Balloon Expandable TransFemoral System

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  Class 1 Device Recall SOLOPATH Balloon Expandable TransFemoral System see related information
Date Initiated by Firm April 26, 2019
Create Date May 28, 2019
Recall Status1 Open3, Classified
Recall Number Z-1374-2019
Recall Event ID 82705
510(K)Number K100819  
Product Classification Introducer, catheter - Product Code DYB
Product 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. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.
Code Information Lot Codes: UG22 UG28A UK02 VA20 VN17 UG22 UK26 VA25 VC15 VG22 VN30 UH29 VA05 VG07 VG26 UH29 VH21 VK29 UH29 UK30 UP20 VF31 WG13 WK30 UH28 UK26 UL28 VD09 VH31 VM19 WP12 UG22 UG22A UH27 UH27A UL14 VA19 VG22 VM24 VP13 WG13 WL28 UG22 UH29 UL14 UL28 UN16 UP20 VA13 VC15 VD09 VH28 VK21 VL06 VL28 VM24 VN21 WG13 XA30 UG22 UL14 UN28 VH27 WM31 UN28 VG02 VP07 WN07
Recalling Firm/
Manufacturer
Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information Contact Nancy Leclair
732-412-4163
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ONSET MEDICAL CORPORATION
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