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.
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.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
These labels are deterministic app interpretations, not FDA categories.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Code information
Model 0161 UDI-DI/GTIN 00802526372766; Model 0164 UDI-DI/GTIN N/A; Model 0165 UDI-DI/GTIN 00802526377259; Model 0167 UDI-DI/GTIN N/A 00802526373251; Model 0170 UDI-DI/GTIN 00802526373282 00802526373299; Model 0171 UDI-DI/GTIN 00802526373374 00802526373381; Model 0172 UDI-DI/GTIN 00802526373466; Model 0173 UDI-DI/GTIN 00802526373558 00802526373565; Model 0174 UDI-DI/GTIN 00802526373640; Model 0175 UDI-DI/GTIN 00802526373732 00802526373749; Model 0176 UDI-DI/GTIN 00802526376726 00802526376733; Model 0177 UDI-DI/GTIN 00802526376818 00802526376825; Model 0180 UDI-DI/GTIN 00802526411977 00802526422027 00802526433597 00802526531149 00802526540943 00802526540950 00802526591518; Model 0181 UDI-DI/GTIN 00802526411984 00802526422034 00802526433689 00802526433726 00802526433757 00802526491009 00802526502903 00802526531156; Model 0182 UDI-DI/GTIN 00802526422041 00802526531163; Model 0183 UDI-DI/GTIN 00802526422058 00802526531170; Model 0184 UDI-DI/GTIN 00802526412011 00802526422065 00802526433986 00802526433993 00802526491313 00802526531187 00802526541261 00802526583438; Model 0185 UDI-DI/GTIN 00802526412028 00802526413438 00802526422072 00802526434082 00802526434099 00802526434105 00802526434150 00802526434174 00802526470622 00802526491405 00802526491412 00802526491429 00802526503306 00802526531194 00802526541346 00802526591563 00802526612541; Model 0186 UDI-DI/GTIN 00802526412035 00802526422089 00802526434198 00802526531200; Model 0187 UDI-DI/GTIN 00802526412042 00802526422096 00802526531217
Distribution pattern
Worldwide Distribution. US nationwide. International distribution worldwide.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
These labels are deterministic app interpretations, not FDA categories.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Code information
Model 0282 UDI-DI/GTIN 00802526431371; Model 0283 UDI-DI/GTIN 00802526431388 00802526504181; Model 0285 UDI-DI/GTIN 00802526431401; Model 0286 UDI-DI/GTIN 00802526431418; Model 0292 UDI-DI/GTIN 00802526431432 00802526474668 00802526480096 00802526485763 00802526504396 00802526531248 00802526541742 00802526552441 00802526611186; Model 0293 UDI-DI/GTIN 00802526431449 00802526531255 00802526541827 00802526552526 00802526554490 00802526611179; Model 0295 UDI-DI/GTIN 00802526431463 00802526474699 00802526531262 00802526541902 00802526554506 00802526611131; Model 0296 UDI-DI/GTIN 00802526431470 00802526474705 00802526480164 00802526480188 00802526531279 00802526541988 00802526552038
Distribution pattern
Worldwide Distribution. US nationwide. International distribution worldwide.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
These labels are deterministic app interpretations, not FDA categories.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Code information
Model 0657 UDI-DI 00802526560934; Model 0682 UDI-DI 00802526560958; Model 0683 UDI-DI 00802526560965; Model 0685 UDI-DI 00802526560972; Model 0686 UDI-DI 00802526560989; Model 0692 UDI-DI 00802526519017 00802526560996 00802526568664 00802526568688; Model 0693 UDI-DI 00802526518850 00802526519055 00802526537769 00802526561009 00802526568701; Model 0695 UDI-DI 00802526519093 00802526561016; Model 0696 UDI-DI 00802526519987 00802526561207 00802526568831
Distribution pattern
Worldwide Distribution. US nationwide. International distribution worldwide.
