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Vapotherm
VAPOTHERM, INC. · Model PF-DPC-HIGH-AJ6 · UDI-DI 00841737104902
BTT
Prescription
10
510(k) clearances
19,179
Adverse events (126 deaths)
70
Recalls
108
Facilities
Description
Precision Flow Disposable Patient Circuit, High AJ6 (Made in Mexico Medica DPC High) (Customer Facing)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Medline Industries, LP | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, |
| 2025-09-18 | Fisher & Paykel Healthcare, Ltd. | When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 |
| 2024-04-02 | Fisher & Paykel Healthcare, Ltd. | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, interm |
| 2022-12-16 | Vapotherm | 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 |
| 2021-01-05 | Hamilton Medical AG | When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into th |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c |
| 2019-12-13 | TELEFLEX MEDICAL INC | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the c |
| 2015-04-01 | Teleflex Medical | Customer complaints were received of power to the unit ceasing and the display going blank. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.