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Incident · Recall

FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure

Edwards Lifesciences issued a Field Corrective Action for OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula models after discovering that a 3-4mm section of wire from the wire-reinforcement coil at the cannula tip could become exposed, risking major tissue damage, arterial puncture, bleeding, and hemolysis. No serious injuries or deaths reported as of May 20, 2025. The FDA classified this as the most serious type of recall.

Occurred 2025-05-16 · SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA · Edwards Lifesciences · Los Angeles, California, USA · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure

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Sources (1)

  1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/arterial-cannula-recall-edwards-lifesciences-removes-arterial-cannula-due-risk-wire-exposure

Status history

  • Active · 2026-07-07 · agent:depth

Common questions

What happened in FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure?
Edwards Lifesciences issued a Field Corrective Action for OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula models after discovering that a 3-4mm section of wire from the wire-reinforcement coil at the cannula tip could become exposed, risking major tissue damage, arterial puncture, bleeding, and hemolysis. No serious injuries or deaths reported as of May 20, 2025. The FDA classified this as the most serious type of recall.
When did this incident occur?
The incident is recorded as occurring on May 16, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure?
SAPIEN 3 Transcatheter Heart Valve by Edwards Lifesciences is the recorded robot involved in this incident at Los Angeles, California, USA.
Has anyone responded to FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-07-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-21

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure.

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Canonical ID c6a40461-8632-444b-b03e-e61f5c91ceef