Intuitive Surgical, Inc. recalls
11 recalls on record · FDA
Every recall we have on record for Intuitive Surgical, Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S,…
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si…
Due to increased complaints for broken/frayed grip cables for reusable instruments.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073…
Access Port System tray may develop cracks potentially resulting in a sterility breach.
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45…
As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.