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Recall Observatory FDA recall evidence

Device product

EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

Z-2105-2015

June 02, 2015

Class II

Product summary

Firm
ArthroCare Corporation
Event
Event 71468
Status
Terminated
Classification
Class II
Quantity
733 devices
Official record key
device-enforcement:Z-2105-2015

Official wording

Reason: Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

Code information: Lot numbers 1093290 and 1091254

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.