ArthroCare Corporation: Medical Device Recall in 2015 - (Recall #: Z-2105-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 2, 2015

Date Posted: July 29, 2015

Recall Number: Z-2105-2015

Event ID: 71468

Reason for Recall:

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

Status: Terminated

Product Quantity: 733 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated