Home / Recalls / Intuitive Surgical, Inc. / Z-2949-2020

Z-2949-2020 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
September 16, 2020
Initiation Date
June 10, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67 units

Product Description

Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.

Reason for Recall

One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or incorrectly engaged to the ION Fully Articulating Catheter which can result in retention of cleaning chemical or water during reprocessing; may cause failure of the ION Fully Articulating Catheter or ION System.

Distribution Pattern

U.S.: California, Colorado, Florida, Illinois, Massachusetts, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, and Virginia. No foreign consignees.

Code Information

All lots.

Other recalls by Intuitive Surgical, Inc.

  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
  • Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: (December 9, 2025)
  • Z-1698-2026 Class II — Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1696-2026 Class II — Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d (December 9, 2025)
  • Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1701-2026 Class II — Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da V (December 9, 2025)
  • Z-1134-2026 Class II — Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Ca (December 4, 2025)
  • Z-1428-2026 Class II — Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used fo (November 17, 2025)