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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80481

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 23, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2501-2018
Recall number
Z-2501-2018
Initiated
March 23, 2018
Classification
Class II
Status
Terminated
Quantity
1,283 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.