Food, drugs, devices › ArthroCare Medical Corporation
Device recall: EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resect
ArthroCare Medical Corporation (Austin, TX) initiated this device recall on 15 May 2015; FDA lists 2 product records under event 71311, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 27 Jun 2016. Initiation: voluntary: firm initiated. ArthroCare Medical Corporation has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ArthroCare Medical Corporation, Austin, TX.
Reason for recall
"Potential component failure causing device inoperability"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1832-2015 | 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,… | 4,111 units | Class II | Terminated | 1 Jul 2015 |
| Z-1833-2015 | PROcise XP Wand with Integrated Cable REF EICA8872-01 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,… | 2,355 units | Class II | Terminated | 1 Jul 2015 |
Context
Other enforcement events for ArthroCare Medical Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Feb 2015 | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical sy | Device | Class II | 1 |
| 27 Oct 2014 | Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient K | Device | Class II | 1 |
| 9 Dec 2013 | Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only | Device | Class II | 1 |
All 4 events for ArthroCare Medical Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential component failure causing device inoperability"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.