Recall Z-0489-2021 ยท EOQ Bronchoscope (Flexible Or Rigid)
Intuitive Surgical, Inc.
Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | The distal tip ring of the fully articulating catheter may become dislodged during the procedure. |
| Root cause | Device Design |
| Action | On 10/23/2020, the firm sent an "Urgent Medical Device Correction" Notification to customers via a courier service informing them of the potential for the distal tip ring to become dislodged. All lots of the affected product (VER: 08) are potentially impacted. The Recalling Firm is instructing customers to: 1.) Prior to start of the procedure, with the Vision Probe fully inserted and connected to the back end of the Catheter, ensure that the Vision Probe does not extend beyond the Catheter. a. If the Vision Probe extends past the Catheter do not use the Catheter in a procedure. 2.) At the end |
| Quantity | 454 catheters |
| Distribution | US Nationwide distribution including in the states of CA, CO, DC, FL, IA, IL, MA, MD, MI, MN, NC, NJ, NY, OH, PA, TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical, Feb 14, 2019 |