Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Terumo Medical Corporation is recalling 1,481 units of the Portico Solo Re-Collapsible Access System, Model Numbers PRTSOLO-19 and PRTSOLO-20. The recall was initiated because there is a potential for the tip to dislodge from the outer diameter of the sheath. This defect can result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
The affected products were distributed nationwide in the United States and in the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, and Singapore. The specific lot codes associated with this recall are VG29, VH28, VK09, VM20, VN08, VP07, WM03, WM31, VG05, VG09, VG21, VK18, VL25, VM11, VN17, VN27, WM03, and WM17.
Healthcare providers and patients should stop using the affected devices and contact Terumo Medical Corporation for further instructions on how to return or replace the products.
The recalled product
- Product
- Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 1,481
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Terumo Medical Corporation
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- HighTerumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- ModerateTerumo 30G Needle Recall Due to Potential Sterility Compromise
FDA (Devices) · 2019-07-31
- ModerateTerumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
- HighTerumo 18G Needles Recalled for Potential Loss of Package Integrity
FDA (Devices) · 2019-07-31
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
Similar recalls
- SevereCalifornia Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk
FDA (Devices) · 2013-01-16
- ModerateTerumo Destination Renal Guiding Sheath Recalled for Missing Coating
FDA (Devices) · 2017-05-10
- HighTerumo Sternal Retractor Locking Mechanism Recall for Fracture Risk
FDA (Devices) · 2021-04-14
- HighTerumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage
FDA (Devices) · 2016-09-14
- HighTerumo Advanced Perfusion System Recalled for Potential Electrical Short
FDA (Devices) · 2018-10-03
- HighTerumo Recalls Titan Stabilizer Attachments Due to Suction Tubing Clip Breakage Risk
FDA (Devices) · 2017-03-01