Pounce Venous Thrombectomy System VTS-0018-09010Recalls & reported problems
Surmodics, Inc. · Pounce Venous Thrombectomy System · Class 2
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 00812339030319), received between May 16, 2024 and May 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
- Material Deformation1
- Off-Label Use1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2024Fracture; Off-Label Use; Detachment of Device or Device Component; Material Deformation; Fracture; Off-Label Use; Detachment of Device or Device Component; Material Deformation
THE POUNCE VENOUS DEVICE WAS USED IN THE PATIENT'S LEFT AND RIGHT LEGS FOR THROMBECTOMY TREATMENT. A 12FR STANDARD INTRODUCER WAS USED AT BOTH POPLITEAL ACCESS POINTS. APPROXIMATELY FOUR TO FIVE DEVICE PASSES WERE PERFORMED IN THE LEFT LEG BEFORE MOVING TO THE RIGHT LEG. PRIOR TO INSERTION INTO THE RIGHT POPLITEAL ARTERY, THE DEVICE WAS DEEMED ACCEPTABLE FOR FURTHER PASSES. AFTER THE FIRST PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE PULLING THE BASKET BACK INTO THE INTRODUCER SHEATH AND WAS UNABLE TO BRING THE BASKET DOWN SUFFICIENTLY WITH THE HANDLE'S CAM OR REAR SLIDE. UPON ATTEMPT TO RE-SHEATH THE BASKET WITH THE OUTER SHEATH THE BASKET FURTHER DEFORMED, AND IT WAS CONFIRMED THAT THE HANDLE WAS NO LONGER ABLE TO COMMUNICATE WITH THE DISTAL END OF THE DEVICE (INABILITY TO EXPAND/COLLAPSE BASKET). FURTHER ATTEMPTS CAUSED THE MID-SHAFT TO FULLY FRACTURE, SEPARATING THE HANDLE FROM THE DEVICE LEAVING JUST THE SHAFT OF THE DEVICE. SEVERAL ATTEMPTS TO RECAPTURE OR REMOVE THE BASKET WERE UNSUCCESSFUL, ULTIMATELY REQUIRING A VENOUS CUT-DOWN AT THE ACCESS SITE TO REMOVE THE BASKET. THE BASKET/CATHETER WAS SUCCESSFULLY REMOVED, AND IT WAS NOTED THAT THE BASKET WAS PACKED FULL WITH CLOT. PA
Patient problems: Foreign Body In Patient
MAUDE report 19332250 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
- Indigo System LITNG12HTORQ115-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration4 deaths105 reports
- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 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.
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