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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812339030791), received between Dec 5, 2025 and Dec 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Handling Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Break; Material Separation; Device Handling Problem; Break; Material Separation; Device Handling Problem
THE POUNCE VENOUS DEVICE WAS USED TO TREAT A PATIENT'S LOWER LEG EXTREMITY WITH SUB-ACUTE/CHRONIC MORPHOLOGY WITH NO SIGNIFICANT TORTUOSITY. IT WAS REPORTED THAT AFTER 3-4 PASSES, UPON REMOVAL OF THE DEVICE, A PIECE OF THE BASKET HAD SEPARATED FROM THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN DID EXPERIENCE RESISTANCE WHILE WITHDRAWING THE DEVICE FROM THE BODY. DURING THE INVESTIGATION OF THE COMPLAINT, IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT DEFEAT THE HEMOSTASIS VALVE ON THE 12FR POUNCE SHEATH DEVICE WHILE WITHDRAWING THE POUNCE VENOUS DEVICE FROM THE BODY WHICH COULD HAVE CONTRIBUTED TO THE RESISTANCE FELT UPON WITHDRAWAL OF THE DEVICE. THE PHYSICIAN WAS ABLE TO REMOVE THE CLOT WITH A SECOND DEVICE IN CONJUNCTION WITH BALLOON VENOPLASTY. THERE WAS NO REPORTED HARM TO THE PATIENT OR SIGNIFICANT PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23732649 ↗
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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