CLASS II Device recall · Reported 25 Jul 2018 · FDA Enforcement Report
Visualase Cooled Laser Applicator System (Vclas) labeled as recalled
Medtronic Navigation is recalling Visualase Cooled Laser Applicator System (Vclas) labeled as: a, distributed nationwide in the US. The recall was initiated on 23 Mar 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2501-2018
- FDA event ID
- 80481
- Recalling firm
- Medtronic Navigation, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2018
- FDA classified
- 19 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 23 Mar 2018 | Recall initiated by company | |
| 19 Jul 2018 | Classified by FDA | +118 days |
| 25 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew York
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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)
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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