Z-1375-2019Class I

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

Name: Z-1375-2019 SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235...
Creator: Terumo Medical Corporation
Published: 2019-04-26
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2019-04-26 / Terminated / root cause: design

FDA source

Terumo Medical Corporation began a recall of SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435 on 2019-04-26. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1375-2019
Classification: Class I
Status: Terminated
Initiated: 2019-04-26
Posted: 2019-05-28
Terminated: 2020-09-22
Recalling firm: Terumo Medical Corp.
Product: SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Product code: DYB Introducer, Catheter
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1375-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28
Z-1375-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28
Z-1376-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28

Product code DYB

K152498Class IISoloPath Re-Collapsible Access SystemOnset Medical Corporation / cleared 2016-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)