FDAFDA · Food and drugs·Recall number Z-1443-2021
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Published April 28, 2021 · Recall initiated: March 8, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BIOTRONIK Inc
- Distributor
- US: Nationwide OUS: Worldwide
- Lot
- Serial Number 60713356 60713357 60713358 60713359 60713360 60713361 60713362 60713363 60713364 60713365 60715282 60715285 60715286 60715287 60715288 60715292 60715293 60715296 60715299 60715300 60715301 60716193 60716194 60716195 60716196 60716197 60716198 60716199 60716201 60716203 60716204 60716205 60716208 60716210 60716597 60716598 60716599 60716600 60716603 60716604 60716606 60716608 60716611 60716612 60716613 60716615 60716616 60716647 60716648 60716651 60716652 60716653 60716654 60716655 60716656 60717982 60717984 60717985 60717988 60717989 60717994 60717995 60717996 60717998 60717999 60718001 60718002 60718003 60718004 60718005 60718006 60718007 60718008 60718010 60718013 60718014 60718015 60718017 60718020 60718024 60718026 60718027 60718028 60718030 60718031 60718032 60718033 60718035 60718039 60718043 60718044 60718045 60718046 60718048 60718054 60718055 60718059 60718061 60718067 60718957 60718958 60718959 60718961 60718963 60718966 60718967 60718969 60718970 60718971 60718972 60718973 60718974 60718976 60718977 60718978 60718980 60718984 60718987 60718988 60718989 60718990 60718991 60718992 60718993 60718994 60718996 60718999 60719000 60719001 60719003 60719700 60719701 60719702 60719704 60719707 60719710 60719719 60719720 60719721 60719726 60719729 60719736 60721875 60721880 60721881 60721885 60721886 60721893 60721895 60721896 60721899 60721900 60721901 60721902 60721904 60721905 60722827 60722828 60722830 60722834 60722835 60722836 60722837 60722838 60722840 60722841 60722842 60722843 60722844 60722846 60725187 60725191 60725859 60725862 60725864 60725870 60725873 60725884 60725890 60725891 60725893 60725895 60725906 60726586 60726600 60728581 60728582 60728583 60728599 60728600 60728602 60728603 60728604 60728605 60728606 60728607 60728610 60728611 60728613 60728614 60728618 60729349 60729350 60729352 60729356 60729357 60729358 60729360 60729370 60729372 60729374 60729375 60729376 60729377 60729620 60729621 60729622 60729623 60729624 60729626 60729627 60729630 60729632 60729642 60729644 60729645 60729657 60730172 60730177 60730178 60730180 60730181 60730182 60730185 60730188 60730191 60730192 60730193 60730195 60730196 60730197 60730903 60730904 60730906 60730909 60730920 60730923 60730928 60730931 60730934 60730935 60730936 60730938 60730940 60731292 60731294 60731297 60731298 60731302 60731303 60731304 60731305 60731306 60731310 60731312 60731313 60731314 60731926 60731929 60731935 60731945 60731949 60731951 60731952 60731953 60731954 60731955 60731958 60733614 60733619 60733623 60733626 60733975 60733979 60734220 60734223 60734224 60734225 60734227 60734228 60734229 60734900 60734901 60734902 60734905 60734909 60735081 60735082 60735083 60735085 60735086 60735088 60735095 60735097 60735099 60735100 60735101 60735102 60735108 60735188 60735189 60735190 60735191 60735192 60735193 60735194 60735196 60735197 60735199 60735201 60735204 60735205 60735208 60735211 60735212 60735213 60735215 60735221 60735222 60735223 60735224 60735225 60735226 60735228 60735229 60735233 60735234 60735235 60735236 60735237 60735239 60736145 60736146 60736147 60736148 60736149 60736150 60736151 60736152 60736154 60736156 60736157 60736159 60736160 60736161 60736162 60736163 60736164 60736166 60736167 60736168 60736169 60736173 60736174 60736304 60736305 60736306 60736307 60736308 60736310 60736311 60736312 60736313 60736314 60736315 60736317 60736318 60736319 60736321 60736322 60736323 60736325 60736326 60736329 60736464 60736468 60736469 60736470 60736472 60737247 60737249 60737253 60737255 60737256 60738378 60738380 60738381 60738383 60738
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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