Pounce ™ XL Thrombectomy PTS-1011-7F135Recalls & reported problems
Surmodics, Inc. · Pounce XL Arterial Thrombectomy Sytem · 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 00812339030807), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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 Remove1
- Fracture1
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.
InjuryJul 10, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove
A PATIENT PRESENTED WITH NO FLOW THROUGH A 6MM GRAFT FROM THE RIGHT COMMON FEMORAL ARTERY (RCFA) TO THE POSTERIOR TIBIAL ARTERY (PT). LEFT COMMON FEMORAL ACCESS WAS OBTAINED USING A 7F SHEATH, LATER EXCHANGED FOR AN 8F SHEATH TO ACCOMMODATE MULTIPLE THROMBECTOMY PASSES. TWO SUCCESSFUL PASSES WERE COMPLETED USING THE POUNCE XL IN CHRONIC RIGHT-SIDED VESSELS AND THE OCCLUDED BYPASS SEGMENT. DURING A THIRD PASS THROUGH THE NATIVE RCFA, A SUBSTANTIAL QUANTITY OF ORGANIZED THROMBUS WAS CAPTURED IN THE DEVICE FUNNEL AND BASKETS. UPON ATTEMPTING TO REMOVE THE LOADED SYSTEM THROUGH THE 8F SHEATH, RESISTANCE WAS ENCOUNTERED. THIS WAS PRESUMED TO BE DUE TO THE THROMBUS VOLUME BURDENING THE LUMEN CLEARANCE OF THE SHEATH. ADDITIONAL TRACTION WAS APPLIED, WHICH RESULTED IN THE INNER LINING OF THE SHEATH BEING PULLED INWARD AND/OR STRIPPED. THIS LED TO THE ALLEGED DETACHMENT OF THE FUNNEL AND BASKETS FROM THE POUNCE SYSTEM. DEVICE COMPONENTS (STILL ENGAGED WITH THROMBUS) BECAME ENTRAPPED WITHIN THE VASCULATURE. DURING A FOLLOW-UP PHONE CALL, THE MANUFACTURER REPRESENTATIVE COULD NOT CONFIRM IF THE DEVICE BASKETS HAD SEPARATED FROM THE BASKET WIRE. A SURGICAL CUTDOWN OF THE LEFT COMMON FEMORAL AR
Patient problems: Foreign Body In Patient
MAUDE report 22476060 ↗
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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