FDA Device recall Z-2105-2015
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation,…
- FDA Device
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation,… by Arthrocare, citing wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2105-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-02 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arthrocare |
| Distribution | US |
Product
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.
Reason
Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.
Identifiers
| code_info | Lot numbers 1093290 and 1091254 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2105-2015%22
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