Merlin 2 PCS MER3700 programmer Model MER3400 software
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling the Merlin 2 PCS MER3700 programmer Model MER3400 software due to a software anomaly that can occur during a specific clinical test. When performing a pacing capture Decrement Test on implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillator devices, the programmer may fail to stop the test and restore the patient's permanently programmed pacing settings. This issue has affected 401 devices worldwide, including distribution across all U.S. states and numerous countries. The affected devices are Model MER3400 software Version v1.X.X with specific serial numbers beginning with 13000001 through 13000182.
The recall record does not specify a remedy or action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
Reason for recall: Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters. Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA Quantity: 401 devices with software Lot/code info: Model MER3400 software Version: v1.X.X UDI: 05415067037121 Serial Numbers of affected Systems: 13000001 13000002 13000003 13000004 13000005 13000006 13000007 13000008 13000009 13000010 13000011 13000014 13000015 13000016 13000017 13000019 13000021 13000023 13000024 13000025 13000026 13000027 13000028 13000029 13000030 13000032 13000033 13000034 13000035 13000036 13000037 13000038 13000039 13000040 13000041 13000042 13000043 13000044 13000045 13000046 13000048 13000049 13000050 13000051 13000052 13000053 13000054 13000057 13000059 13000061 13000062 13000063 13000064 13000065 13000066 13000067 13000068 13000069 13000070 13000071 13000073 13000075 13000076 13000077 13000079 13000081 13000082 13000083 13000084 13000085 13000086 13000087 13000088 13000090 13000091 13000092 13000093 13000094 13000095 13000096 13000099 13000100 13000101 13000102 13000103 13000104 13000105 13000106 13000107 13000108 13000109 13000110 13000111 13000112 13000113 13000114 13000115 13000116 13000118 13000119 13000121 13000124 13000126 13000127 13000128 13000129 13000130 13000131 13000132 13000133 13000134 13000135 13000137 13000139 13000140 13000141 13000142 13000143 13000144 13000146 13000147 13000148 13000149 13000150 13000151 13000152 13000153 13000154 13000155 13000156 13000157 13000158 13000159 13000160 13000161 13000162 13000163 13000164 13000165 13000166 13000168 13000169 13000170 13000171 13000172 13000173 13000174 13000175 13000176 13000177 13000178 13000179 13000180 13000181 13000182 13000184 1
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.