Amplatzer™ TorqVue™ 9-TV2-05F120Recalls & reported problems
St. Jude Medical, Inc. · 2 Delivery Sheath · Class 2
All models of Amplatzer TorqVue (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811806012476), received between Feb 20, 2024 and Feb 20, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL INFORMATION: CRD_967 - PARADIGM, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 10MMX5MM AMPLATZER VALVULAR PLUG 3 WAS SUCCESSFULLY IMPLANTED IN A PATIENT USING A 5F AMPLATZER TORQVUE 2 DELIVERY SHEATH. ON (B)(6) 2024, IT WAS NOTED THAT THE PATENT WENT TO THE EMERGENCY ROOM DUE TO TESTICULAR PAIN. THE PATIENT WAS FOUND TO HAVE ORCHITIS AND A SCROTAL HEMATOMA. IT BELIEVE THAT THE CAUSE WAS FROM VENOUS ACCESS DURING THE IMPLANT PROCEDURE.
Patient problems: Hematoma; Pain
MAUDE report 18743890 ↗
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page