ArthroCare Plasma Wand Devices Recalled for Dielectric Specification Failures
ArthroCare Corporation is recalling 733 EVac 70 XTRA and PROcise EZ View plasma wand devices because they were released without meeting dielectric specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to meet dielectric safety specifications, creating a risk of harm (electrical shock) that has not yet been reported as an injury, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ArthroCare Corporation is recalling 733 units of EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable plasma wand devices. The recall affects lot numbers 1093290 and 1091254. These devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
The recall was initiated because the wands were inspected with an adaptor fixture and found to have been released to the field without meeting dielectric (Hipot) specifications. The devices were distributed worldwide, including in the United States, Australia, Belgium, Germany, Spain, the United Kingdom, Ireland, India, Italy, and Singapore.
Healthcare providers and facilities should stop using the affected devices and contact ArthroCare Corporation for further instructions regarding the recall.
The recalled product
- 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,
- Manufacturer
- ArthroCare Corporation
- Hazard
- Affected units
- 733
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot numbers 1093290 and 1091254
Distribution
Distributed nationwide across the United States.
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