AESCULAP GF399RRecalls & reported problems
Aesculap AG · Suction Cannula, 7", (180 mm), working length: 4 1/2", (115 mm), diam. 4 mm, tapered, teardrop, medium, 12FR, non-sterile, reusable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653435913), received between Jan 4, 2024 and Jan 4, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
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.
InjuryJan 4, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO AESCULAP INC. ON USER FACILITY MEDWATCH REPORT # (B)(4) THAT A SUCTION TUBE TAPERED TEARDROP 12FR 180MM (PART # GF399R) WAS USED DURING AN UNSPECIFIED PROCEDURE ON (B)(4). 2023. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE HAD BROKEN. REPORTEDLY, "ALL PIECES WERE RETRIEVED." THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445377 ↗
Other APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED devices
- StrykeFlow 0250070520Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED2 recalls250 reports
- StrykeFlow 0250070505Stryker Corporation · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall3 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571315Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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