Coapt Dome Electrode, Gen2 system, cutaneous electrode
Reported: November 8, 2023 Initiated: October 2, 2023 #Z-0203-2024
Product Description
Coapt Dome Electrode, Gen2 system, cutaneous electrode
Reason for Recall
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Details
- Recalling Firm
- Coapt LLC
- Units Affected
- 247 devices
- Distribution
- Worldwide distribution - US Nationwide and the country of Sweden.
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
Coapt Dome Electrode, Gen2 system, cutaneous electrode. Recalled by Coapt LLC. Units affected: 247 devices.
Why was this product recalled? ▼
Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0203-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11