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.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. has recalled 454 units of the ION Fully Articulating Catheter (Model 490105-08) distributed nationwide across 18 states including California, Texas, New York, and others. The catheter is used to navigate within the lung to reach a planned path during medical procedures. The reason for the recall is that the distal tip ring of the catheter may become dislodged during the procedure, which could affect the device's functionality.
The recalled catheters were manufactured across various lot numbers between September 2018 and April 2020, as identified by their serial numbers beginning with "S10." The recall record does not specify a remedy or instructions for what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The distal tip ring of the fully articulating catheter may become dislodged during the procedure.
Reason for recall: The distal tip ring of the fully articulating catheter may become dislodged during the procedure. 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. Quantity: 454 catheters Lot/code info: 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 S10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.