APRO 70 Swift Catheter FG-02133-132-ACRecalls & reported problems
Alembic, LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850014025267), received between Aug 7, 2025 and Mar 3, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (2 reports).
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
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Damaged by Another Device1
- Material Integrity Problem1
- Physical Resistance/Sticking1
- Stretched1
Patient problems
- Intracranial Hemorrhage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Break; Device Damaged by Another Device; Material Deformation; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE APRO CATHETER WAS BEING EXTRACTED FROM THE INTRODUCER SHEATH IT STARTED TO UNRAVEL AND HAD PLASTIC COMING WITH IT. THE EVENTS LEADING UP TO THE PROCEDURE INCIDENT WERE AS FOLLOWS: THE BALT BALLAST INTRODUCER SHEATH WAS INTRODUCED INTO THE RIGHT ICA, THE APRO CATHETER WAS INTRODUCED THROUGH THE GUIDE SHEATH, THEN THE SOLITAIRE WAS INTRODUCED INTO THE SHEATH. THE SOLITAIRE WAS UNABLE TO BE RETRIEVED THROUGH THE INTRODUCER SHEATH. ALL ITEMS HAD TO BE REMOVED TOGETHER. UPON REMOVAL OF THE ITEMS IN ONE UNIT IT WAS NOTICED THE APRO WAS FRAYED. THE PATIENT SUFFERED DAMAGE FROM THE FRAYED APRO AND WAS IN CRITICAL CONDITION. THIS CONTRADICTS THE EARLIER REPORT THAT THE APRO APPEARED TO BE INTACT.
Patient problems: Intracranial Hemorrhage
MAUDE report 24498406 ↗MalfunctionAug 7, 2025Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED IT IS ASSUMED THAT THE COPILOT TOUGHY WASN'T PUSHED IN ENOUGH CAUSING THE STRETCHING. POST PROCEDURE TICI WAS 2B. CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22742238 ↗
Other Catheter, Thrombus Retriever devices
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- 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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