Maquet Equipment ARDEQT239015ARecalls & reported problems
Maquet Sas · EQTXS3216 11 · Class 1
All models of Maquet Equipment (45)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700712414306), received between Jan 30, 2025 and Jan 30, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL EQUIPMENT - EQTXS3216. IT WAS STATED THE PAINT WAS BUBBLING/CHIPPING ON THE SPRING ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273222 ↗MalfunctionJan 30, 2025Peeled/Delaminated; Peeled/Delaminated
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273092 ↗
Other HOLDER, CAMERA, SURGICAL devices
- Maquet Equipment ARDSAT239020AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- NA ARDEQT269002AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDSAT239022AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDEQT239016AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDSAT239007AMaquet Sas · Holder, Camera, Surgical1 recall1 report
- Maquet Equipment ARDEQT639023AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 reports
- Maquet Equipment ARDSAT639005AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 reports
- Maquet Equipment ARDSAT639019AMaquet Sas · HOLDER, CAMERA, SURGICAL1 recall0 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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