Amplatzer™ TorqVue™ 9-TVLP5F90/080Recalls & reported problems
St. Jude Medical, Inc. · LP Delivery System · Class 2
All models of Amplatzer TorqVue (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806011592), received between Jan 20, 2020 and Nov 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Failure to Advance1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
MalfunctionJan 20, 2020Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance
ON (B)(6) 2019, A 5/4 MM PDA OCCLUDER WAS SELECTED FOR IMPLANT USING A TORQUE DELIVERY SYSTEM 5FR 90/080. DURING THE PROCEDURE, THE OCCLUDER FAILED TO ADVANCE INTO THE DELIVERY SHEATH. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE, BUT IT REMAINED STUCK IN THE LOADING SYSTEM. A NEW 5/4MM PDA OCCLUDER AND TORQUE 5FR 90/080 WERE SELECTED. UPON ADVANCEMENT, THE OCCLUDER WAS STUCK IN THE SHEATH AGAIN, BUT THIS TIME IT WAS SUCCESSFULLY RETRIEVED INTO THE LOADING SYSTEM. A THIRD DELIVERY SYSTEM TORQVUE 6FR WAS SELECTED AND SUCCESSFULLY USED TO IMPLANT THE SECOND PDA OCCLUDER. THE PATIENT IS REPORTED TO BE STABLE. MANUFACTURER REPORT NUMBER: 2135147-2020-00020, 2182269-2020-00001, 2135147-2020-00005.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9606804 ↗
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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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