Reference notice · device
DeRoyal Industries Inc — REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Powell, TN, US · Updated 9/22/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference