Merlin 2 PCS MER3700 programmer
Medical device recall Z-0965-2022. Published in FDA’s Enforcement Report on Apr 27, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 27, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 401 devices with software how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Merlin 2 PCS MER3700 programmer Model MER3400 software
401 devices with software, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,994 characters
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…
FDA’s list runs to 3,703 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 10, 2022.
- FDA classified it on Apr 21, 2022.
- FDA’s Enforcement Report published it on Apr 27, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St. Jude Medical, Cardiac Rhythm Management Division, of Sylmar, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Other.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,703 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.