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Terminated

SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

FDA Recall Z-1375-2019 · Posted 2019-05-28

Recalling FirmTerumo Medical Corporation
Recall StatusTerminated
Product CodeDYB
Date Initiated2019-04-26
Date Terminated2020-09-22
Product Quantity1431

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.

Firm Action

Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.

Root Cause

Device Design

Distribution Pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152498SoloPath Re-Collapsible Access SystemOnset Medical Corporation · 2016-01-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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