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U.S. Department of Health and Human Services

Class 1 Device Recall Portico Solo ReCollapsible Access System

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 Class 1 Device Recall Portico Solo ReCollapsible Access Systemsee related information
Date Initiated by FirmApril 26, 2019
Date PostedMay 28, 2019
Recall Status1 Terminated 3 on September 22, 2020
Recall NumberZ-1376-2019
Recall Event ID 82705
510(K)NumberK152498 
Product Classification Introducer, catheter - Product Code DYB
ProductPortico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Code Information Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17
FEI Number 1118880
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information ContactNancy 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
ActionUrgent Medical Device Recall letters dated 4/26/19 were sent to customers.
Quantity in Commerce1481
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = DYB
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