Esperance 3+ Aspiration Catheter System ASP3F120KITRecalls & reported problems
Shanghai Wallaby Medical Technologies Co., Inc. · The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06970908213625), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 death.
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
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
EMERGENT THROMBECTOMY PERFORMED. DURING THE THIRD PASS FOR THROMBECTOMY, PART OF THE ESPERANCE ASPIRATION CATHETER BROKE OFF INTO PATIENT'S RIGHT MIDDLE CEREBRAL ARTERY. THE PIECE WAS RETRIEVED USING A STENT RETRIEVER; HOWEVER, SIGNIFICANT BLEEDING WAS NOTED. ESPERANCE CATHETER: MANUFACTURER:WALLABY MEDICAL LOT#: ASP00572, REF#: ASP3F120KIT, EXP: 2025.12.06 .THE WIRE USED WITH THE CATHETER:DRIVEWIRE24. MANUFACTURER: RAPID MEDICAL LOT#: 250301DW01, REF#: DRPP2411, EXP: 01.31.2026.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22723992 ↗
Other Catheter, Thrombus Retriever devices
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- Penumbra System 3MAXCPenumbra, Inc. · CATHETER, THROMBUS RETRIEVER1 death241 reports
- EMBOTRAP ET309537Neuravi Limited · Catheter, Thrombus Retriever13 deaths177 reports
- ACE 5MAXACE068KITPenumbra, Inc. · CATHETER, THROMBUS RETRIEVER170 reports
- Embotrap ET009533Neuravi Limited · Catheter, Thrombus Retriever16 deaths153 reports
- Penumbra System 5MAXACE132Penumbra, Inc. · CATHETER, THROMBUS RETRIEVER3 deaths112 reports
- Penumbra System 5MAXJET7KIT-APenumbra, Inc. · Catheter, Thrombus Retriever1 death94 reports
- Trevo XP 90185Stryker Corporation · CATHETER, THROMBUS RETRIEVER1 recall1 death40 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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