Vapotherm PF-DPC-LOW-BAG-MXRecalls & reported problems
Vapotherm, Inc. · Precision Flow Disposable Patient Circuit, Low Mexico Made · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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 00841737104971), received between Sep 9, 2024 and Sep 9, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 16, 2022Class IIOpen, Classified
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.
Z-1272-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Degraded1
- Fluid/Blood Leak1
Patient problems
- Apnea1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2024Degraded; Fluid/Blood Leak; Degraded; Fluid/Blood Leak
THIS INCIDENT HAPPENED IN THE UK AND IS BEING REPORTED PER THE GUIDANCE PROVIDED BY FDA ON 21 CFR 803. THIS INCIDENT WAS ON VAPOTHERM'S PRECISION FLOW SYSTEM WHICH IS AN OPEN SYSTEM WITH A NASAL CANNULA TO TREAT PATIENTS IN RESPIRATORY DISTRESS. CUSTOMER STATED THAT INFANT/NEONATAL PATIENT WAS BEING TREATED WITH VAPOTHERM HIGH VELOCITY THERAPY ON THE PRECISION FLOW DEVICE. THE PATIENT WAS BEING TREATED FOR LONG TERM ON THE DEVICE AND WAS IN THE PROCESS OF BEING WEANED OFF THE THERAPY. EXCESSIVE CONDENSATION WAS OBSERVED TO BE EXITING THE DEVICE AND SPURTING FROM THE PATIENT'S NOSE WHILE BEING MONITORED. PATIENT SUBSEQUENTLY BECAME APNOEIC. PATIENT WAS RESUSCITATED WITH NEOPUFF AND RECOVERED QUICKLY. PATIENT WAS BEING FURTHER MONITORED.
Patient problems: Apnea
MAUDE report 20176497 ↗
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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 · each recall links to the FDA recall notice
- 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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