Z-2501-2018Class II

Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser...

Name: Z-2501-2018 Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser...
Creator: Medtronic Navigation, Inc.
Published: 2018-03-23
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2018-03-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560... on 2018-03-23. FDA classified it as Class II and gives the reason as "Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2501-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-23
Posted: 2018-07-19
Terminated: 2023-07-31
Recalling firm: Medtronic Navigation, Inc
Product: Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase Cooled Laser Applicator System 10mm Tip; c. Part Number 9735561 Visualase Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 nm - 1060 nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Customers were notified on about 03/23/2018 via URGENT: MEDICAL DEVICE RECALL letter. Instructions included to examine inventory for affected devices, contact Medtronic Technical Services at 1-888-826-5603 to arrange for the return of affected devices, and complete and return the Consignee Response Form. The recall was later expanded and customers were notified on about 05/16/2018 URGENT: MEDICAL DEVICE RECALL letter. Instructions did not change from the initial letter, but informed customers that the recall had been expanded to include two (2) additional lots.
Quantity in commerce: 1,283 devices total
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. International distribution to Israel.
Product codes and lots: a. Part Number 9735559, UDI (00643169611986, 00643169933361), Lot Codes (0212782059, 0212894256, 0213251294, 0213331774, 0213383266, 0212783784, 0212926008, 0213259125, 0213335148, 0213383267, 0212823883, 0212956163, 0213299882, 0213375479, 0213387215, 0212823919, 0212978141, 0213299885, 0213378982, 0213537710, 0212854585, 0212996201, 0213327285, 0213383244, 0213966003, 0212882619, 0213519510); b. Part Number 9735560, UDI (00643169611993, 00643169933385), Lot Codes (0212086315, 0213158249, 0213299883, 0213427083, 0213728326, 0212698642, 0213158631, 0213304570, 0213455321, 0213735817, 0212715926, 0213158719, 0213304571, 0213458938, 0213737565, 0212745633, 0213165510, 0213304573, 0213507022, 0213760863, 0212753561, 0213165511, 0213308717, 0213507023, 0213760864, 0212756095, 0213205023, 0213309087, 0213512428, 0213760866, 0212760821, 0213205024, 0213334598, 0213512430, 0213769912, 0212827856, 0213208868, 0213368255, 0213513054, 0213917334, 0212838837, 0213212692, 0213368499, 0213513055, 0213922188, 0212843810, 0213223891, 0213368573, 0213513056, 0213924407, 0212846727, 0213223892, 0213373657, 0213540031, 0213924418, 0212856596, 0213242839, 0213374559, 0213576515, 0213928892, 0212873863, 0213245723, 0213375535, 0213576516, 0213945813, 0212873873, 0213258625, 0213375537, 0213576517, 0213945814, 0212879480, 0213259039, 0213375538, 0213594271, 0213966370, 0212913269, 0213259673, 0213375991, 0213594272, 0213972422, 0212922387, 0213259674, 0213376135, 0213594273, 0213973527, 0212935278, 0213267742, 0213376136, 0213596471, 0214032331, 0213000097, 0213289058, 0213376138, 0213699385, 0214043408, 0213001255, 0213289059, 0213376139, 0213699386, 0214045295, 0213009483, 0213292765, 0213376655, 0213699390, 0214049428, 0213041517, 0213292893, 0213376656, 0213710007, 0214062101, 0213044327, 0213296890, 0213376780, 0213710711, 0214066559, 0213056030, 0213296891, 0213377536, 0213710712, 0214068011, 0213107317, 0213298978, 0213378061, 0213720928, 0214068013, 0213116115, 0213299342, 0213387201, 0213720929, 0214068921, 0213134866, 0213299525, 0213388160, 0213728324, 0214068922, 0213136534, 0213518754, 0213138278); c. Part Number 9735561, UDI (00643169612006, 00763000015695, 00643169933378), Lot Codes (0212701679, 0212912501, 0212991152, 0213647807, 0213669275, 0212707035, 0212935757, 0213555835, 0213662428, 0213669402, 0212745660, 0212939348, 0213555836, 0213663333, 0213669408, 0212796559, 0212963182, 0213645747, 0213663500, 0213670155, 0212846726, 0212965542, 0213645760, 0213667299, 0213670722, 0212901580, 0212904407)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2501-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2501-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-25	2018-07-19

Product code GEX

K053087Class IIVisualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc. / cleared 2006-03-01

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)