The Recall Desk
HighFDA (Devices)·Z-0924-2025·Announced 2025-01-22

FDA Recalls Small Graptor Retractor Instruments Due to Cable Failures

Intuitive Surgical is recalling 42,028 Small Graptor surgical retractor instruments used with da Vinci X/Xi systems due to pitch cable failures. The recalled devices affect surgical facilities nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a surgical instrument with pitch cable failure risk. No injuries or hospitalizations have been reported in the source text, but the failure mode could impact instrument control during surgery, representing potential risk of harm to patients.

Plain-English summary

Intuitive Surgical, Inc. is recalling 42,028 Small Graptor (REF 470318) surgical retractor instruments used with da Vinci X/Xi Surgical Systems. These instruments are used in a variety of surgical procedures for tissue manipulation and retraction.

The devices are being recalled due to an increase in complaints regarding pitch cable failures in the small Graptor instruments. These cable failures could potentially impact the ability to control the instrument during surgery.

The recalled devices were distributed nationwide in the United States, Puerto Rico, and internationally to Canada, Europe, Asia, South America, Africa, and Australia. Affected lot numbers are identified by specific part number versions (470318-04, 470318-07, 470318-08, and 470318-10) with detailed lot numbers listed by Intuitive Surgical.

Healthcare providers and surgical facilities using affected devices should discontinue use and contact Intuitive Surgical for replacement. Patients who have received procedures using these instruments should consult their healthcare provider if they have concerns.

The recalled product

Product
8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
42,028

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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