FDA recall Z-2693-2020

Medtronic Sofamor Danek USA Inc · Class II · device

Product

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to indicate gauge size. The ACCURIAN RF Cannula included in the ACCURIAN RF Ablation Platform intended for the creation of radiofrequency lesions in nervous tissue.

Reason for recall

Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.

Key facts

Status
Terminated
Initiation date
2020-06-08
Report date
2020-07-29
Termination date
2022-05-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2693-2020