The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1832-2015·Announced 2015-07-01

ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure

ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential component failure causing inoperability without reported injuries or illnesses, fitting the criteria for a moderate severity rating.

Plain-English summary

ArthroCare Medical Corporation is recalling 4,111 units of the EVAC 70 XTRA with Integrated Cable (REF EICA5872-01) plasma wand. These medical devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery, including procedures such as adenoidectomy, tonsillectomy, and laryngeal polypectomy.

The recall is being conducted because of a potential component failure that may cause the device to become inoperable. The affected units were distributed nationwide in the United States. The specific lot numbers involved are 1092289, 1092288, 1092287, 1092284, 1092276, and 1085237, all with an expiration date of 09JAN2017.

Healthcare providers and facilities should stop using the affected devices and contact ArthroCare Medical Corporation for further instructions on how to return or dispose of the units.

The recalled product

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…
Manufacturer
ArthroCare Medical Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4,111

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 (6)

  • Lot Numbers: 1092289
  • 1092288
  • 1092287
  • 1092284
  • 1092276
  • 1085237 (Expiration date: 09JAN2017)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ArthroCare Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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