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U.S. Department of Health and Human Services

Class 2 Device Recall Merlin 2 Patient Care System (PCS) software

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  Class 2 Device Recall Merlin 2 Patient Care System (PCS) software see related information
Date Initiated by Firm March 10, 2022
Create Date April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0965-2022
Recall Event ID 89816
PMA Number P030054S389 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Merlin 2 PCS MER3700 programmer Model MER3400 software
Code Information 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 13000185 13000186 13000187 13000188 13000189 13000190 13000191 13000192 13000193 13000194 13000196 13000197 13000198 13000199 13000200 13000201 13000202 13000203 13000204 13000205 13000206 13000207 13000208 13000209 13000210 13000211 13000212 13000213 13000216 13000217 13000219 13000220 13000221 13000224 13000225 13000226 13000227 13000228 13000231 13000232 13000233 13000234 13000235 13000236 13000237 13000238 13000239 13000240 13000241 13000242 13000244 13000245 13000246 13000248 13000249 13000250 13000251 13000252 13000253 13000254 13000255 13000256 13000257 13000258 13000259 13000260 13000261 13000262 13000264 13000265 13000267 13000268 13000269 13000270 13000271 13000272 13000273 13000276 13000277 13000278 13000279 13000280 13000281 13000282 13000283 13000284 13000285 13000286 13000287 13000288 13000289 13000291 13000292 13000294 13000295 13000296 13000297 13000298 13000300 13000301 13000302 13000303 13000304 13000305 13000306 13000307 13000308 13000309 13000310 13000311 13000312 13000313 13000314 13000315 13000316 13000317 13000319 13000320 13000321 13000322 13000324 13000325 13000326 13000327 13000328 13000329 13000331 13000332 13000333 13000334 13000335 13000336 13000337 13000338 13000339 13000340 13000341 13000342 13000343 13000344 13000346 13000347 13000348 13000349 13000350 13000351 13000352 13000353 13000354 13000355 13000356 13000357 13000358 13000359 13000360 13000361 13000362 13000363 13000364 13000365 13000366 13000367 13000368 13000369 13000370 13000372 13000373 13000374 13000375 13000376 13000377 13000378 13000379 13000380 13000381 13000383 13000388 13000389 13000390 13000391 13000393 13000394 13000395 13000396 13000397 13000398 13000399 13000401 13000403 13000404 13000405 13000406 13000408 13000409 13000411 13000412 13000413 13000414 13000415 13000416 13000418 13000419 13000420 13000421 13000423 13000424 13000425 13000426 13000427 13000428 13000429 13000430 13000431 13000432 13000433 13000435 13000436 13000437 13000438 13000439 13000440 13000441 13000442 13000445 13000446 13000447 13000450 13000451 13000452 13000455 13000456 13000457 13000458 13000459 13000466 13000468 13000469 13000472 13000495 13000496 13000520 13000536 13000544 13000545 13000557
Recalling Firm/
Manufacturer		 St. Jude Medical, Cardiac Rhythm Management Division
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Alicia Swanson
408-845-3427
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action The Recalling firm is sending an "Urgent Medical Device Correction" Letter to physicians and healthcare professionals informing them of a programmer software anomaly that may be encountered when executing a pacing capture Decrement Test in-clinic on a Gallant, or Entrant device using a Merlin Patient Care System (PCS) programmer. If a user presses the Hold to Test button and decides to stop testing by releasing the button prior to the first voltage decrement (within a narrow time window approximately 2.5 seconds after test initiation), the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters. Customers instructions/recommendations regarding patient management: The Recalling Firm has developed updated software (v25.4X rev 1 or higher) which will correct this issue. A Recalling Firm Representative will be upgrading the programmer software beginning in March 2022. For any questions, contact Abbott Technical Support at 1-800-722-3774.
Quantity in Commerce 401 devices with software
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 RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NIK and Original Applicant = Abbott Medical
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