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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Hazard
- Affected units
- 42,028
Distribution
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.
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