THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electroph

FDA device recall Z-0169-2023 · posted 2022-11-02 · Open, Classified

Recall details

Recalling firm

Johnson & Johnson Surgical Vision, Inc.

Reason for recall

Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.

Action taken

On 09/07/2022, recall notices were mailed and emailed to customers requesting the following: 1) Ensure that anyone in your facility who needs to be aware of this notification reads the notice carefully. 2) If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this letter to the relevant personnel. 3) Discard/Destroy the device as per your standard disposal process, ensuring it cannot be used. 4) Complete and return the business response form. Questions can be directed to the recalling firm representative. The following email address was provided: OneMD-Field-Actions@its.jnj.com

Root cause

Process control

Status

Open, Classified

Product code

OAD

Quantity affected

91

Distribution

Worldwide - US Nationwide distribution in the states of NC, TN, VA, OH, MO, MI, GA, OR, MO, SD, CO, OH, FL, NJ, TX, IL, WI and the countries of CROATIA, GERMANY, HUNGARY.

Date initiated

2022-09-07

Date posted

2022-11-02

Location

Irvine, CA