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U.S. Department of Health and Human Services

Class 2 Device Recall Ion Endoluminal System

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  Class 2 Device Recall Ion Endoluminal System see related information
Date Initiated by Firm October 23, 2020
Create Date November 25, 2020
Recall Status1 Terminated 3 on December 05, 2022
Recall Number Z-0489-2021
Recall Event ID 86664
510(K)Number K182188  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product 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
Code Information Model Number: 490105-08 UDI: 00886874116258 Lot/Serial Number: All S10181217 S10190103 S10190424 S10190424 S10190424 S10190531 S10190531 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190605 S10190610 S10190610 S10190625 S10190625 S10190710 S10190802 S10190802 S10190823 S10190823 S10190823 S10190823 S10190823 S10190829 S10190829 S10190829 S10190829 S10190829 S10190829 S10190911 S10190911 S10190911 S10190911 S10190911 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191016 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191023 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191106 S10191203 S10191203 S10191203 S10191203 S10191203 S10191203 S10191210 S10191210 S10191210 S10191210 S10191210 S10191216 S10191216 S10191216 S10191217 S10191217 S10191217 S10191231 S10191231 S10191231 S10191231 S10191231 S10191231 S10200107 S10200107 S10200107 S10200107 S10200107 S10200107 S10200110 S10200110 S10200110 S10200110 S10200110 S10200110 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200220 S10200227 S10200227 S10200304 S10200304 S10200304 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200311 S10200323 S10200323 S10200323 S10200323 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200328 S10200403 S10200403 S10200403 S10200403 S10200403 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200415 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200423 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200504 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200514 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200521 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200526 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200623 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200709 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200723 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200815 S10200820 S10200820 S10200820 S10200825 S10200825 S10200825 
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
866-255-2071
Manufacturer Reason
for Recall		 The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
FDA Determined
Cause 2		 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 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 Recalls@intusurg.com Att
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Intuitive Surgical
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