The Recall Desk
ModerateFDA (Devices)·Z-1833-2015·Announced 2015-07-01

ArthroCare Medical Recalls PROcise XP Wand Due to Component Failure

ArthroCare Medical is recalling 2,355 PROcise XP Wand units because a potential component failure may cause the device to become inoperable during use.

What this means for you

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 resulting in inoperability. No injuries, illnesses, or deaths are reported in the source text, and the risk is limited to device malfunction rather than direct physical harm.

Plain-English summary

ArthroCare Medical Corporation is recalling 2,355 units of the PROcise XP Wand with Integrated Cable (REF EICA8872-01). The recall is due to a potential component failure that may result in the device becoming inoperable. The affected lot numbers are 1092290, 1092291, and 1092292.

The PROcise XP Wand is a plasma wand device indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery. The device is intended for procedures using a conductive media, such as normal saline or Ringer's lactate. The recall covers units distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected devices and contact ArthroCare Medical Corporation for further instructions on the recall process.

The recalled product

Product
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, ora
Manufacturer
ArthroCare Medical Corporation
Category
Medical Device — Surgical Instrument
Hazard
Affected units
2,355

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 (3)

  • Lot Numbers: 1092290
  • 1092291
  • 1092292

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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