Linvatec Corp. dba ConMed Linvatec REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908. ConMed Linvatec LIGHTWAVE SUCTION ABLATOR, electrosurgical cutting and coagulation device and accessories, intended to remove tissue and control bleeding by use of high-frequency electrical current.
Brand
Linvatec Corp. dba ConMed Linvatec
Lot Codes / Batch Numbers
All lots manufactured from July 2004 to September 2008: Lot Numbers: 0407121, 0407151, 0407211, 0407271, 0411151, 0411221, 0411291, 0412081, 0412111, 0502161, 0502211, 0504281, 0505021, 0505061, 0505091, 0505101, 0505121, 0505161, 0505171, 0505231, 0506021, 0506131, 0507051, 0508121, 0508221, 0508251, 0509061, 0511021, 0511091, 0511301, 0602231, 0604241, 0606071, 0606191, 0610271, 0611011, 0703121, 0703191, 0704021, 0704091, 0704121, 0705091, 0705231, 0706041, 0706221, 0706271, 0707241, 0708031, 0708131, 0708201, 0711261, 0711301, 0801072, 0801152, 0802132, 0802202, 0803072, 0803112, 0803262, 0803312, 0804171, 0804292, 0805022, 0805061, 0805062, 0806092, 0806262, 0807142, 0807232, 0807292, 0808052, 0808132, 0809032, 0809052, and 0809262.
Products Sold
All lots manufactured from July 2004 to September 2008: Lot Numbers: 0407121, 0407151, 0407211, 0407271, 0411151, 0411221, 0411291, 0412081, 0412111, 0502161, 0502211, 0504281, 0505021, 0505061, 0505091, 0505101, 0505121, 0505161, 0505171, 0505231, 0506021, 0506131, 0507051, 0508121, 0508221, 0508251, 0509061, 0511021, 0511091, 0511301, 0602231, 0604241, 0606071, 0606191, 0610271, 0611011, 0703121, 0703191, 0704021, 0704091, 0704121, 0705091, 0705231, 0706041, 0706221, 0706271, 0707241, 0708031, 0708131, 0708201, 0711261, 0711301, 0801072, 0801152, 0802132, 0802202, 0803072, 0803112, 0803262, 0803312, 0804171, 0804292, 0805022, 0805061, 0805062, 0806092, 0806262, 0807142, 0807232, 0807292, 0808052, 0808132, 0809032, 0809052, and 0809262.
Linvatec Corp. dba ConMed Linvatec is recalling REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONC due to ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/pat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ConMed Linvatec has determined there is a possibility that the device may not shut off if the ablate button is released, which may result in users/patients suffering burns.
Recommended Action
Per FDA guidance
ConMed Linvatec is notifying their direct consignees by an Urgent Medical Device Recall letter, requesting that customers check their inventory for the affected products; complete, sign, and return the Reply Form; and return of any affected lot numbers of the product. The product is to be returned to ConMed Linvatec. Questions should be directed to Customer Service at 1-800-237-0169.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026