Portico Solo™ PRTSOLO-19 (UDI 25415067028154)Recalls & reported problems
St. Jude Medical, Inc. · Re-Collapsible Introducer Hydrophillic Coated 11F Comparable Sheath ID 19F Expanded Profile · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 25415067028154), received between May 11, 2018 and May 11, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Physical Resistance1
Patient problems
- Blood Loss1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Physical Resistance; Physical Resistance
THE USER FACILITY REPORTED THAT THE PORTICO SOLO-19 DEVICE WAS INSERTED PER THE IFU AND THE BALLOON WAS EXPANDED AS PER THE IFU INSTRUCTIONS. WHEN LOADED THE PORTICO DELIVERY SYSTEM WAS INTRODUCED AND ENORMOUS RESISTANCE WAS ENCOUNTERED. THE DELIVERY SYSTEM THEN BECAME LODGED IN THE SOLOPATH SHEATH. THE DOCTORS WERE UNABLE TO ADVANCE OR REMOVE THE LOADED DELIVERY SYSTEM. THE ENTIRE SOLOPATH SHEATH AND LOADED DELIVERY SYSTEM WERE REMOVED AND WAS REPLACED WITH AN ULTIMUM 18FR, RESULTING IN INCREASED PROCEDURAL TIME, COMPLICATIONS AND PROCEDURAL PRECAUTIONS ON REMOVING THE ULTIMUM SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. ON (B)(6) 2018, A 19FR. PORTICO SOLO WAS INSERTED AND THE BALLOON WAS EXPANDED AS PER IFU INSTRUCTION. AN 18FR. A PORTICO DELIVERY SYSTEM LOADED WITH A 25MM PORTICO VALVE (SN: (B)(4)) WAS INTRODUCED INTO THE PORTICO SOLO SHEATH, AND ENORMOUS RESISTANCE ENCOUNTERED. THE DELIVERY SYSTEM WAS LODGED IN THE PORTICO SOLO SHEATH AND THE USERS WERE UNABLE TO ADVANCE OR REMOVE THE LOADED DELIVERY SYSTEM. THE ASSEMBLED PORTICO SOLO SHEATH AND DELIVERY SYSTEM WERE REMOVED AND EXCHANGED FOR AN ULTIMUM 18F, ANOTHER 18FR. DELIVERY SYSTEM (LOT NUMBER: 6021002) AND
Patient problems: Blood Loss; No Consequences Or Impact To Patient
MAUDE report 7507278 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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