Recall Z-1832-2015— ArthroCare Medical Corporation

Name: FDA recall Z-1832-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-15

Class II · Terminated

Class II FDA medical device recall by ArthroCare Medical Corporation, initiated 2015-05-15, terminated 2016-06-27. It names one FDA 510(k) clearance: K142999. 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.. Reason: Potential component failure causing device inoperability.

Recalling firm: ArthroCare Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Terminated: 2016-06-27
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K142999 — EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated CableArthroCare Corporation·cleared 2014-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential component failure causing device inoperability

Data sourced from openFDA. This site is unofficial and independent of the FDA.