Vapor 3000 M36500Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675301363), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Gas Output Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K971923); 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
Recalls naming this device
- Nov 24, 2025Open, Classified
A certain component of affected devices was not delivered within specification and contained impurities.
Z-0934-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Gas Output Problem1
- Inaccurate Delivery1
Patient problems
- Oversedation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Gas Output Problem; Inaccurate Delivery
BY MEANS OF AN UFR, DRÄGER WAS NOTIFIED ABOUT AN ADVERSE EVENT OCCURRED DURING USE OF AN ANESTHETIC GAS VAPORIZER OF TYPE DRÄGER VAPOR 3000. A SIGNIFICANT OVERDOSE WAS REPORTEDLY OBSERVED DURING A SURGICAL PROCEDURE; THE PATIENT BECAME BRADYCARDIC AND HYPOTENSIVE, REQUIRING THE ADMINISTRATION OF ATROPINE FOR STABILIZATION. IT WAS MENTIONED THAT NO FINAL HEALTH CONSEQUENCES WERE RESULTING FROM THE EVENT.
Patient problems: Oversedation
MAUDE report 24159522 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K971923. One submission often covers many models, so check the product and lot details in each record.
- Z-0933-2026 · Nov 24, 2025 · Open, ClassifiedDraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Other Vaporizer, Anesthesia, Non-Heated devices
- TEC 850 SEVDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall2,251 reports
- TEC 850 ISODatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall184 reports
- TEC 6 PLUS VAP DES 120V ESDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall63 reports
- TEC 820 SEVDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall59 reports
- TEC 6 PLUS VAP DES 220/240V ENDatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall48 reports
- TEC 820 ISODatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED1 recall31 reports
- Vapor 2000 M35054Drägerwerk AG & Co. KGaA · Vaporizer, Anesthesia, Non-Heated1 recall8 reports
- TEC 6 PLUS VAP DES 120V USADatex-Ohmeda Inc · VAPORIZER, ANESTHESIA, NON-HEATED36 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.