PlainRecalls
FDA Devices Moderate Class II Terminated

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - 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.

Reported: July 29, 2020 Initiated: June 8, 2020 #Z-2691-2020

Product Description

Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - 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.

Details

Units Affected
481 pk
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Belgium and Australia.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - 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.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 481 pk.
Why was this product recalled? ▼
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2691-2020.

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