Alsius CoolGard Temperature Regulation System recallZ-0369-06 · Alsius Corporation · initiated Nov 9, 2005
Terminated All recalls posted in January 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alsius Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
FDA root cause category: Other
What the company is doing
Alsius Corporation is notifying customers of an issue requiring service of their CoolGard 3000 by letter shipped via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt.
Recall details
- Recall number
- Z-0369-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 9, 2005
- Posted by the FDA
- Jan 10, 2006
- Recalling firm
- Alsius Corporation
- Quantity
- 239
- Product code
- NCX
- FDA submissions
- K014241, K030421
- Distribution
- Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom
Product description
Alsius CoolGard Temperature Regulation System
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Serial # 30000011 30000012 30000013 30000014 30000016 30000017 30000018 30000019 30000020 30000022 30000023 30000024 30000025 30000026 30000027 30000029 30000030 30000031 30000032 30000033 30000034 30000035 30000036 30000037 30000038 30000039 30000040 30000041 30000042 30000043 30000044 30000045 30000046 30000047 30000048 30000049 30000050 30000051 30000052 30000053 30000054 30000055 30000056 30000057 30000058 30000059 30000060 30000061 30000062 30000063 30000064 30000065 30000066 30000068 30000069 30000070 30000071 30000072 30000073 30000074 30000075 30000076 30000077 30000078 30000079 30000081 30000082 30000083 30000084 30000085 30000086 30000087 30000088 30000089 30000090 30000091 30000092 30000093 30000094 30000095 30000096 30000097 30000098 30000100 30000101 30000102 30000103 30000104 30000105 30000106 30000107 30000108 30000109 30000110 30000111 30000112 30000113 30000114 30000115 30000116 30000117 30000118 30000119 30000120 30000121 30000122 30000123 30000124 30000125 30000126 30000127 30000128 30000129 30000130 30000131 30000132 30000133 30000134 30000136 30000138 30000139 30000140 30000141 30000142 30000143 30000144 30000145 30000146 30000147 30000148 30000149 30000150 30000151 30000152 30000154 30000155 30000156 30000157 30000158 30000159 30000160 30000162 30000163 30000164 30000165 30000166 30000167 30000168 30000169 30000170 30000171 30000172 30000173 30000174 30000175 30000176 30000177 30000178 30000179 30000180 30000181 30000182 30000183 30000184 30000185 30000186 30000187 30000188 30000189 30000190 30000191 30000192 30000193 30000194 30000195 30000196 30000197 30000198 30000199 30000200 30000201 30000202 30000203 30000204 30000205 30000206 30000207 30000208 30000209 30000210 30000211 30000212 30000213 30000214 30000215 30000216 30000217 30000218 30000219 30000220 30000221 30000222 30000223 30000224 30000225 30000226 30000227 30000228 30000229 30000230 30000232 30000233 30000234 30000235 30000236 30000237 30000238 30000239 30000240 30000241 30000242 30000243 30000244 30000245 30000246 30000247 30000248 30000249
Other devices under the same FDA submission
2 devices cleared under K014241, K030421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Start-Up Kit CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling8 reports
- Start-Up Kit Custom Luer CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling1 death4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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