Z-1022-2011

PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured...

Name: Z-1022-2011 PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured...
Creator: Peak Surgical
Published: 2009-05-19
License: https://open.fda.gov/license/

Peak Surgical, Inc. / initiated 2009-05-19 / Terminated

FDA source

Peak Surgical began a recall of PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The... on 2009-05-19. The reason FDA records is "A customer reported that a patient suffered a burn while using the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1022-2011
Status: Terminated
Initiated: 2009-05-19
Posted: 2011-02-02
Terminated: 2011-04-21
Recalling firm: Peak Surgical, Inc.
Product: PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040; Product is manufactured and distributed by PEAK Surgical, Palo Alto, CA The PEAK Surgery System is indicated for the cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopedic, Arthroscopic, Spinal and Neurological procedures.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: A customer reported that a patient suffered a burn while using the device.
FDA root cause: Other
Action: Peak Surgical notified afftected customers by phone on May 19, 2009. They were notified of the product, the problem, and the action to be taken. Peak Surgical sales representatives removed PlasmaBlade EXT devices from consignees affected by the recall.
Quantity in commerce: 493 units
Distribution: Worldwide Distribution - United States including CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, and WAand the countries of Turkey and Ireland
Product codes and lots: Lot Numbers: 11673, 12061, 12237, 12393, 12485

Product code GEI

K082786Class IIPulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. / cleared 2008-12-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)