CLASS I Device recall · Reported 5 Jun 2019 · FDA Enforcement Report

Solopath Re-Collapsible Access System recalled by Terumo Medical

Terumo Medical is recalling Solopath Re-Collapsible Access System, distributed nationwide in the US. The recall was initiated on 26 Apr 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot 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

Quantity recalled1431

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1375-2019
FDA event ID: 82705
Recalling firm: Terumo Medical, Elkton, MD
Classification: Class I
Status: Terminated
Recall initiated: 26 Apr 2019
FDA classified: 28 May 2019
Reported: 5 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Apr 2019	Recall initiated by company
28 May 2019	Classified by FDA	+32 days
5 Jun 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82705

This product is part of a recall event; the main page for the event is Solopath Balloon Expandable TransFemoral System recalled.

Reported	Class	Recall	Company	Reason	Where
5 Jun 2019	CLASS I	Solopath Balloon Expandable TransFemoral System recalled	Terumo Medical	Other	Nationwide
5 Jun 2019	CLASS I	Portico Solo Re-Collapsible Access System recalled by Terumo Medical	Terumo Medical	Other	Nationwide

More recalls from Terumo Medical

All 39

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Glidesheath Slender A-kit 6f .021gw recalled by Terumo Medical	Terumo Medical	Packaging Defects	Nationwide
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide