Z-1832-2015Class II

EVAC 70 XTRA with Integrated Cable REF EICA5872-01

Name: Z-1832-2015 EVAC 70 XTRA with Integrated Cable REF EICA5872-01
Creator: ArthroCare Medical Corporation
Published: 2015-05-15
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2015-05-15 / Terminated / root cause: design

FDA source

ArthroCare Medical Corporation began a recall of 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... on 2015-05-15. FDA classified it as Class II and gives the reason as "Potential component failure causing device inoperability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1832-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Posted: 2015-06-25
Terminated: 2016-06-27
Recalling firm: ArthroCare Corporation
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Potential component failure causing device inoperability
Root cause tag: design
FDA root cause: Component design/selection
Action: Smith & Nephew sent an Urgent Product Recall notification letter dated May 15, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, quarantine immediately and return to the address listed on the inventory Return Certification Form.
Quantity in commerce: 4,111 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: 1092289, 1092288, 1092287, 1092284, 1092276, 1085237 (Expiration date: 09JAN2017)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1832-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1832-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25
Z-1833-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-25

Product code GEI

K142999Class IIEVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated CableArthroCare Corporation / cleared 2014-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)