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

Portico Solo Re-Collapsible Access System recalled by Terumo Medical

Terumo Medical is recalling Portico Solo 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: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17

Quantity recalled1481

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-1376-2019
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

Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

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: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17

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	Solopath Re-Collapsible Access System recalled by Terumo Medical	Terumo Medical	Other	Nationwide

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