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ArthroCare Medical Corporation recalls EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, re
Recalled July 1, 2015 · FDA recall Z-1832-2015 · ArthroCare Medical
Hazard
Potential component failure causing device inoperability · FDA Class II
Units
4,111 units
Sold at
US Nationwide Distribution
Description
Potential component failure causing device inoperability
Product
EVAC 70 XTRA with Integrated Cable REF EICA5872-01 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 by 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.
Manufacturer(s)
ArthroCare Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →