CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report
Evac 70 Xtra with Integrated Cable recalled by ArthroCare Medical
ArthroCare Medical is recalling Evac 70 Xtra with Integrated Cable, distributed nationwide in the US. The recall was initiated on 15 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1832-2015
- FDA event ID
- 71311
- Recalling firm
- ArthroCare Medical, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2015
- FDA classified
- 25 Jun 2015
- Reported
- 1 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 May 2015 | Recall initiated by company | |
| 25 Jun 2015 | Classified by FDA | +41 days |
| 1 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential component failure causing device inoperability
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Potential component failure causing device inoperability
Which lots are affected?
Lot Numbers: 1092289, 1092288, 1092287, 1092284, 1092276, 1085237 (Expiration date: 09JAN2017)
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 71311| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | PROcise XP Wand with Integrated Cable recalled by ArthroCare Medical | ArthroCare Medical | Device Malfunction | Nationwide |
More recalls from ArthroCare Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PROcise XP Wand with Integrated Cable recalled by ArthroCare Medical | ArthroCare Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Coblator II System, 120V recalled by ArthroCare Medical | ArthroCare Medical | Other | Nationwide |
| Device | CLASS II | Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated recalled | ArthroCare Medical | Sterility | Nationwide |
| Device | CLASS II | Arthrocare Sports Medicine, Knot Pusher recalled by ArthroCare Medical | ArthroCare Medical | Other | Nationwide |
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| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |