CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

Cardiac Probe Grasper recalled by Intuitive Surgical

Intuitive Surgical is recalling Cardiac Probe Grasper, distributed in 8 states. The recall was initiated on 3 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Quantity recalled509 total units, all affeced devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0440-2015
FDA event ID: 69638
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2014
FDA classified: 25 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Surgical Instruments

Timeline

3 Nov 2014	Recall initiated by company
25 Nov 2014	Classified by FDA	+22 days
3 Dec 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Where it was distributed

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

Florida Indiana Massachusetts Nevada New York Oregon Texas Utah

Questions about this recall

Is Cardiac Probe Grasper recalled?

Yes. Intuitive Surgical recalled Cardiac Probe Grasper on 3 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0440-2015.

Why was it recalled?

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Which lots are affected?

Part number;470215-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Where was it sold?

US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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