CLASS II Device recall · Reported 17 Aug 2016 · FDA Enforcement Report

Curved-tip Stapler 30,is4000 recalled by Intuitive Surgical

Intuitive Surgical is recalling Curved-tip Stapler 30,is4000, distributed in Puerto Rico. The recall was initiated on 14 Jul 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalled2065 total

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-2350-2016
FDA event ID: 74705
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2016
FDA classified: 5 Aug 2016
Reported: 17 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

14 Jul 2016	Recall initiated by company
5 Aug 2016	Classified by FDA	+22 days
17 Aug 2016	Published in enforcement report	+12 days

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

Reason for recall

An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend

Product as listed by the FDA

CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

Where it was distributed

US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.

Puerto Rico

Questions about this recall

Is Curved-tip Stapler 30,is4000 recalled?

Yes. Intuitive Surgical recalled Curved-tip Stapler 30,is4000 on 14 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2350-2016.

Why was it recalled?

Which lots are affected?

All

Where was it sold?

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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