ArthroCare Medical Corporation recalls PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, re…

Recall date

May 15, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1833-2015

FDA classification

Class II

Brand / firm

ArthroCare Medical Corporation

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential component failure resulting in inoperability

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PROcise XP Wand with Integrated Cable REF EICA8872-01 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.