Z-2051-2009

REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD...

Name: Z-2051-2009 REF IA-2000-S, LightWave Suction Ablator, STERILE, Rx ONLY, MADE IN USA. CONMED LINVATEC, 11311 CONCEPT BLVD...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2009-07-31
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2009-07-31 / Terminated / root cause: design

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of 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... on 2009-07-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2051-2009
Status: Terminated
Initiated: 2009-07-31
Posted: 2009-09-09
Terminated: 2011-02-25
Recalling firm: Linvatec Corporation
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 28,074 units
Distribution: Worldwide Distribution
Product codes and lots: 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.

Product code GEI

K050923Class IILightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorConmed Linvatec / cleared 2005-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)