PV Bulletin

Urgent Withdrawal of Reusable da Vinci S and Si Instruments Due to Cable Degradation

Intuitive Surgical is voluntarily withdrawing certain reusable da Vinci S and Si instruments due to issues with degraded gripping cables, which may affect functionality and patient safety.

Primary source: Consultez le courrier de la société Intuitive Surgical de mars 2026 (09/03/2026)

Translated From French

PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.

PV Impact Brief

Urgency: HighConfidence: high

What changed

Intuitive Surgical has initiated a voluntary recall of certain da Vinci S and Si instruments due to increasing reports of degraded cables that can lead to functional loss and safety issues.

Why it matters

Degraded gripping cables may compromise the functionality of surgical instruments, increasing the risk of incidents during procedures, which could lead to severe injuries or complications for patients.

Action needed

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 7, 2026

Full briefing

Practical implication

Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

The ANSM (France) has issued a safety notification regarding the urgent withdrawal of certain reusable da Vinci S and Si instruments. Complaints of degraded gripping cables have been reported, leading to potential risks to patient safety. Healthcare facilities using these instruments must take immediate action as updated versions are expected to be available by March 2026.

What changed: Intuitive Surgical has initiated a voluntary recall of certain da Vinci S and Si instruments due to increasing reports of degraded cables that can lead to functional loss and safety issues.

Why it matters: Degraded gripping cables may compromise the functionality of surgical instruments, increasing the risk of incidents during procedures, which could lead to severe injuries or complications for patients.

Practical implication: Healthcare facilities must isolate the affected instruments and notify Intuitive Surgical for returns while preparing for potential delays in surgical procedures due to instrument replacements.

View original source

  • Source: ANSM (France) - Safety information feed
  • Published at source: 2026-09-07T00:00:00.000Z
  • Discovered by monitor: 2026-09-07T21:36:51.053Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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