D-Vapor M35500Recalls & reported problems
Drägerwerk AG & Co. KGaA · Class 2
Data updated Oct 16, 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 04048675225195), received between May 7, 2025 and Jul 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K042276); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
- Gas Output Problem1
- Inaccurate Delivery1
- Insufficient Device Problem Information1
- Leak/Splash1
Patient problems
- Insufficient Information1
- Low Blood Pressure/ Hypotension1
- Oversedation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Gas Output Problem; Inaccurate Delivery; Gas Output Problem; Inaccurate Delivery
DRÄGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE VAPORIZER EXHIBITED A SIGNIFICANT AGENT OVERDOSAGE. THE PATIENT REPORTEDLY EXPERIENCED A TEMPORARY HYPOTENSION BUT THE EVENT DID REPORTEDLY NOT LEAD TO HEALTH CONSEQUENCES, FINALLY.
Patient problems: Low Blood Pressure/ Hypotension; Oversedation
MAUDE report 22437234 ↗MalfunctionMay 7, 2025Leak/Splash; Insufficient Device Problem Information; Device Handling Problem; Leak/Splash; Insufficient Device Problem Information; Device Handling Problem
IT WAS REPORTED THAT THERE WAS AN ANESTHETIC AGENT RELEASE DURING FILLING OF THE DEVICE AND THAT THE OPERATOR WAS EXPOSED TO THE EVAPORATING SUBSTANCE. IT IS CURRENTLY NOT KNOWN IF THIS LED TO AN INJURY OR NOT. (THE SUBSTANCE HAS THE POTENTIAL TO CAUSE SERIOUS EYE AND SKIN IRRITATIONS.)
Patient problems: Insufficient Information
MAUDE report 21975053 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042276. One submission often covers many models, so check the product and lot details in each record.
- Z-1812-2016 · Apr 21, 2016 · TerminatedDraeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia 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
- Vapor 3000 M36500Drägerwerk AG & Co. KGaA · Vaporizer, Anesthesia, Non-Heated1 recall1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page