Gyrus ACMI 23116Recalls & reported problems
Gyrus ACMI, LLC · Collection Set, Disposable with Handle and Tapered Fittings Tubing, 6 Ft (183 cm) (10/PK) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925030954), received between Apr 17, 2024 and Oct 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K171440); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product2
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THE COLLECTION SET TUBING PACKAGE WAS RECEIVED IN A WET BOX DUE TO THE HURRICANE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385172 ↗MalfunctionAug 27, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THE COLLECTION SET TUBING PACKAGE HAD A HAIR IN IT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20077401 ↗MalfunctionApr 17, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
IT WAS REPORTED THE DISPOSABLE COLLECTION SET TUBING WAS RECEIVED REPACKAGED AND DAMAGED. THE ISSUE OCCURRED DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124378 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171440. One submission often covers many models, so check the product and lot details in each record.
- Z-0078-2023 · Sep 16, 2022 · Open, ClassifiedBerkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Other Curette, Suction, Endometrial (And Accessories) devices
- BERKELEY VC-10Gyrus ACMI, LLC · Curette, Suction, Endometrial (And Accessories)1 recall8 reports
- BERKELEY SAFE-TOUCH 003853-902Gyrus ACMI, LLC · Curette, Suction, Endometrial (And Accessories)8 reports
- SAFETOUCH 003984-901Gyrus ACMI, LLC · Curette, Suction, Endometrial (And Accessories)2 reports
- Gyrus ACMI 54298Gyrus ACMI, LLC · CURETTE, SUCTION, ENDOMETRIAL (AND ACCESSORIES)2 reports
- Uterine Explora Curette - Model I MX120Coopersurgical, Inc. · Curette, Suction, Endometrial (And Accessories)1 report
- Berkeley Vacurette 21593AGyrus ACMI, LLC · Curette, Suction, Endometrial (And Accessories)1 report
- Gyrus ACMI 003997-901Gyrus ACMI, LLC · Curette, Suction, Endometrial (And Accessories)1 report
- Pipet Curet MX140Coopersurgical, Inc. · Curette, Suction, Endometrial (And Accessories)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.