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
Recall
- Recall Number
- Z-0489-2021
- Event Number
- 86664
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- EOQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 23, 2020
- Terminated
- December 5, 2022
- Address
- 1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304
Description
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
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
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 of the procedure, confirm that the distal tip ring is still intact (with the Vision Probe fully inserted and connected to the backend of the Catheter, confirm that the Vision Probe does not extend beyond the Catheter. a. If the Vision Probe extends past the Catheter, perform fluoroscopy to ensure that the Catheter distal tip ring does not remain in the patient. In addition, please follow the instructions outlined in the Ion System, Instrument and Accessories User Manual (PN 553990), specifically: 1.) Inspect all instruments and accessories for potential damage prior to clinical use. 2.) Use only compatible Cook Captura biopsy forceps. Failure to use compatible forceps may result in stuck forceps or Catheter damage. a. Ensure that the Cook Captura biopsy forceps are fully closed when withdrawing into the Catheter after biopsy. b. Slowly insert and retract (do not use excessive force or rapidly withdraw) the Cook Captura biopsy forceps into the Catheter. If the Catheter distal tip ring is missing at any point during inspection, contact Customer Service immediately and return the Catheter and the distal tip ring, if available, through the standard RMA process. In addition, the Recalling Firm is asking customers to: 1. Inform necessary hospital personnel about this issue 2. Complete the attached Acknowledgement Form and return via email [email protected] Att
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.
454 catheters