Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A
Recall
- Recall Number
- Z-1134-2026
- Event Number
- 98215
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- EOQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 4, 2025
- Posted
- January 21, 2026
- Address
- 1266 Kifer Rd, Sunnyvale, CA, 94086-5304
Description
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
On 12/19/2025, the firm emailed to customer an "Urgent Medical Device Recall" letter informing them that Intuitive has identified that some Vision Probe Bags may have a compromised or incomplete sterile pouch seal. Investigation determined that during the supplier manufacturing and packaging process, the Vision Probe Bag is placed into a separate sterile pouch for sealing. During this step, air trapped inside the Vision Probe Bag can remain within the pouch and expand during sterilization, which may place stress on the sterile-pouch seals and result in partial seal failure, creating a potential sterility breach. Customers are instructed: 1. Identify affected product: Inspect the product label and confirm the product number and lot number. a. Appendix A lists affected Part Numbers and Lot Numbers b. Appendix B provides an example label highlighting the location of the Part Number and Lot Number. 2. If the label displays lot numbers within the affected range shown in Appendix A, inspect the product pouch seal. Do not use the product if the seal is compromised or has an incomplete seal and scrap the affected units in accordance with your facility s disposal procedures. 3. Contact Intuitive Customer Service to obtain credit for any scrapped units. a. Product return to Intuitive is not required. 4. Retain a copy of this letter and the complete Acknowledgment Form for your records. 5. Ensure all relevant personnel within your facility are informed of this correction. For Questions - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or [email protected] " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or [email protected] " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or [email protected] " India: +1-800-103-6952 (9 am to 6 pm IT) Taiwan: +0800-86-8181 (9 am to 6 pm CT)
U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom
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