GYRUS ACMI 5710009Recalls & reported problems
Gyrus ACMI, LLC · SURLOK Flat-Wire Stone Basket 4.5 FR (1.5mm) X 70cm Basket width: 20 mm # of Wires: 4 · 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 00821925010420), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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.
Most reported problems
Device problems
- Device Damaged Prior to Receipt by User1
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.
MalfunctionMar 24, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
CUSTOMER REPORTED WITH AN ISSUE OF WHEN THE PRODUCT WAS RECEIVED , OUTSIDE PLASTIC PACKAGING WAS DAMAGED. THE ISSUE FOUND DURING RECEIPT INSPECTION. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13877710 ↗
Other DISLODGER, STONE, FLEXIBLE devices
- Stone Cone M0063903200Boston Scientific Corporation · DISLODGER, STONE, FLEXIBLE87 reports
- Stone Cone M0063903100Boston Scientific Corporation · DISLODGER, STONE, FLEXIBLE21 reports
- OLYMPUS NT4F19115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE6 reports
- OLYMPUS NT4W18115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE4 reports
- GYRUS ACMI 5711012Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE2 reports
- OLYMPUS NT4W22115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE2 reports
- Talon 00711175US Endoscopy · DISLODGER, STONE, FLEXIBLE1 report
- OLYMPUS NTCP22115Gyrus ACMI, LLC · DISLODGER, STONE, FLEXIBLE1 report
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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