medical MODERATE Updated 2018-02-14

Covidien LLC recalls Covidien Emprint Percutaneous Antenna with Thermosphere Tech

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Recalled Product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

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Hazard / Issue

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall