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U.S. Department of Health and Human Services

Class 1 Device Recall SOLOPATH ReCollapsible Access System

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  Class 1 Device Recall SOLOPATH ReCollapsible Access System see related information
Date Initiated by Firm April 26, 2019
Date Posted May 28, 2019
Recall Status1 Terminated 3 on September 22, 2020
Recall Number Z-1375-2019
Recall Event ID 82705
510(K)Number K152498  
Product Classification Introducer, catheter - Product Code DYB
Product SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925,
SR-1935,
SR-2025,
SR-2035,
SR-2225,
SR-2235,
SR-2425,
SR-2435
Code Information Lot Codes:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09
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 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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ONSET MEDICAL CORPORATION
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