ConMed Recalls HeatWave Electrodes Due to Insulation Damage Risk
ConMed is recalling specific HeatWave Electrodes because damaged shaft insulation could increase the risk of patient burns during arthroscopic procedures.
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 3/5 (High).
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 risk-of-harm product (patient burn) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ConMed Corporation is recalling CONCEPT HEATWAVE Electrodes (REF/Catalog Number CS-023) due to complaints of damage to the electrode's shaft insulation. The product is intended for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.
The recall is being conducted because if the shaft insulation is damaged, it could result in burn marks on the shaft and increase the risk of patient burn. The affected units were manufactured between September 1, 2011, and November 17, 2015, and were distributed worldwide, including in the United States and various foreign countries.
Healthcare providers and facilities should stop using the affected electrodes and contact ConMed Corporation for instructions on how to return or dispose of the product.
The recalled product
- Product
- CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
- Manufacturer
- ConMed Corporation
- Hazard
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 (20)
- All lots codes manufactured from 09/01/2011 through 11/17/2015: 267221
- 301001
- 309889
- 318652
- 319649
- 325019
- 354759
- 334627
- 336041
- 341704
- 343927
- 349952
- 384294
- 354768
- 365239
- 369773
- 374480
- 378521
- 406137
- 385695
Distribution
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