Portico Solo™ PRTSOLO-19 (UDI 15415067028157)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15415067028157), received between May 3, 2017 and Dec 14, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (2 reports).
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
- Difficult to Remove2
- Deflation Problem1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2018Deflation Problem; Deflation Problem
THE USER FACILITY REPORTED A 11F PORTICO SOLOPATH WAS USED FOR A PORTICO IMPLANT. BUT THEY WERE UNABLE TO RE-COLLAPSE THE PORTICO SOLO FOR REMOVAL AFTER THE SUCCESSFULLY IMPLANTATION OF A 25MM PORTICO VALVE. SO THE PHYSICIAN REMOVED IT DIRECTLY. THE PATIENT WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8166269 ↗MalfunctionJun 15, 2017Difficult to Remove; Difficult to Remove
THE USER FACILITY REPORTED THAT THERE WAS A METAL LOOP VISIBLE ON THE SHEATH. THE FOLLOWING INFORMATION WAS REPORTED: A PORTICOSOLO-19 DEVICE WAS USED DURING THE TAVI PROCEDURE; AFTER REMOVING THE PORTICO SOLO DEVICE, THE USER NOTICED THAT A METAL LOOP WAS VISIBLE OUTSIDE OF THE LOCK AT THE END OF THE SHEATH; THE PATIENT WAS REPORTED TO BE STABLE; AND NO INJURIES WERE OBSERVED ON THE PATIENT'S VESSELS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6642950 ↗InjuryMay 3, 2017Difficult to Remove; Difficult to Remove
THE USER FACILITY REPORTED THAT THERE WAS EXTENSIVE UNFOLDING OF THE SHEATH. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A PROGLIDE WAS CUT OUT OF THE PRE-CLOSURE SITE; DUE TO INTERNAL BALLOONING A STENT GRAFT IMPLANTATION WAS NOT NECESSARY; AND THE PATIENT IS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6540219 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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