ASAP® 00884450568385Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 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 00884450568385), received between Jan 25, 2023 and Jan 25, 2023 — classified as 1 death.
The most frequently reported specific device problem is “Material Separation” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJan 25, 2023Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT AN ASPIRATION CATHETER DETACHED WITHIN THE PATIENT'S DISTAL RCA,/PDA BRANCH. THE FOREIGN BODY WAS NOT RETRIEVED BY THE PHYSICIAN. NO ADDITIONAL MEDICATIONS OR SURGICAL INTERVENTIONS NECESSARY.
Patient problems: Foreign Body In Patient; Thrombosis/Thrombus
MAUDE report 16241984 ↗
Other Aspiration thrombectomy catheter devices
- AlphaVac 25-302Angiodynamics, Inc. · Aspiration thrombectomy catheter12 deaths17 reports
- AlphaVac H787253020Angiodynamics, Inc. · Aspiration thrombectomy catheter2 deaths5 reports
- JETi™ WV8803AAbbott Vascular Inc. · Aspiration Thrombectomy Catheter4 reports
- AlphaVac 25-301Angiodynamics, Inc. · Aspiration thrombectomy catheter4 deaths4 reports
- JETi™ WVSDUPAbbott Vascular Inc. · Aspiration Thrombectomy Catheter3 reports
- JETi™ WV6203AAbbott Vascular Inc. · Aspiration Thrombectomy Catheter2 reports
- QuickClear Thrombectomy System AC10SH085Volcano Atheromed, Inc. · Aspiration Thrombectomy Catheter2 reports
- ASAPLP™ 00884450555125Merit Medical Systems, Inc. · Aspiration thrombectomy catheter2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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