Reported Aug 17, 2022 · Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D,…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Cobalt Implantable Cardioverter Defibrillators with Cardiac
- Resynchronization Therapy (CRT-D)a. Cobalt HF CRT-D
- Model Numbers
DTPB2D4DTPB2D1b. Cobalt HF Quad CRT-D
- Model Numbers
DTPB2QQDTPB2Q1
- Lot codes and dates
- a
- Model NumbersDTPB2D4: GTIN 00763000178215
- Serial Numbers
89 of 89 codes
RTO600239SRTO600280SRTO600409SRTO600468SRTO600544SRTO600701SRTO600712SRTO601012SRTO601031SRTO601113SRTO601150SRTO601156SRTO601205SRTO601223SRTO601549SRTO601612SRTO601620SRTO601784SRTO601793SRTO601819SRTO601823SRTO601830SRTO601845SRTO601846SRTO601858SRTO601860SRTO601862SRTO601891SRTO601905SRTO601945SRTO601960SRTO601965SRTO601986SRTO602000SRTO602002SRTO602029SRTO602031SRTO602056SRTO602107SRTO602110SRTO602116SRTO602159SRTO602164SRTO602173SRTO602183SRTO602224SRTO602260SRTO602261SRTO602266SRTO602297SRTO602303SRTO602308SRTO602311SRTO602324SRTO602326SRTO602330SRTO602331SRTO602333SRTO602336SRTO602340S
- Serial Numbers
184 of 184 codes
RTO600028SRTO600029SRTO600030SRTO600031SRTO600033SRTO600034SRTO600036SRTO600037SRTO600038SRTO600040SRTO600041SRTO600042SRTO600043SRTO600045SRTO600046SRTO600047SRTO600048SRTO600049SRTO600050SRTO600051SRTO600052SRTO600053SRTO600054SRTO600055SRTO600056SRTO600057SRTO600058SRTO600060SRTO600061SRTO600062SRTO600064SRTO600067SRTO600069SRTO600070SRTO600136SRTO600606SRTO600906SRTO600960SRTO600966SRTO600967SRTO600970SRTO600971SRTO600972SRTO600973SRTO600974SRTO600975SRTO600977SRTO600978SRTO600980SRTO600983SRTO600984SRTO600985SRTO600986SRTO600988SRTO600989SRTO601010SRTO601016SRTO601018SRTO601022SRTO601077S
- DTPB2D1GTIN 00763000178222
- Serial Numbers
88 of 88 codes
RTP600231SRTP600637SRTP600821SRTP600936SRTP600949SRTP601207SRTP601642SRTP601651SRTP601655SRTP601658SRTP601669SRTP601684SRTP601772SRTP601786SRTP601803SRTP601838SRTP601839SRTP601873SRTP601908SRTP601950SRTP601967SRTP601975SRTP601985SRTP602018SRTP602050SRTP602065SRTP602067SRTP602101SRTP602113SRTP602138SRTP602141SRTP602142SRTP602143SRTP602144SRTP602173SRTP602187SRTP602188SRTP602189SRTP602195SRTP602203SRTP602212SRTP602213SRTP602221SRTP602222SRTP602253SRTP602255SRTP602277SRTP602290SRTP602291SRTP602296SRTP602298SRTP602301SRTP602303SRTP602308SRTP602313SRTP602329SRTP602333SRTP602372SRTP602379SRTP602380S
- Serial Numbers
124 of 124 codes
RTP600011SRTP600013SRTP600014SRTP600015SRTP600022SRTP600023SRTP600024SRTP600025SRTP600026SRTP600027SRTP600028SRTP600029SRTP600032SRTP600035SRTP600037SRTP600039SRTP600043SRTP600044SRTP600045SRTP600046SRTP600047SRTP600049SRTP600051SRTP600055SRTP600056SRTP600058SRTP600061SRTP600062SRTP600064SRTP600265SRTP600318SRTP600325SRTP600337SRTP600363SRTP600364SRTP600365SRTP600367SRTP600369SRTP600370SRTP600371SRTP600376SRTP601365SRTP601366SRTP601367SRTP601368SRTP601369SRTP601370SRTP601371SRTP601374SRTP601375SRTP601376SRTP601377SRTP601378SRTP601379SRTP601380SRTP601381SRTP601382SRTP601383SRTP601384SRTP601385S
- Model NumbersDTPB2QQ: GTIN 00763000178178
- Serial Numbers
98 of 98 codes
RTK600618SRTK600835SRTK601828SRTK602459SRTK602776SRTK602784SRTK602799SRTK602818SRTK602951SRTK603433SRTK603475SRTK603527SRTK603528SRTK604363SRTK604481SRTK604905SRTK604930SRTK604946SRTK605316SRTK605413SRTK605674SRTK605677SRTK605685SRTK605700SRTK605703SRTK605708SRTK605710SRTK605713SRTK605714SRTK605718SRTK605722SRTK605794SRTK605833SRTK605845SRTK605848SRTK605946SRTK606126SRTK606418SRTK606497SRTK606521SRTK606803SRTK606947SRTK607461SRTK607582SRTK607652SRTK608200SRTK608230SRTK608281SRTK608312SRTK608428SRTK608654SRTK608660SRTK608677SRTK608684SRTK608694SRTK608698SRTK608703SRTK608756SRTK608774SRTK608786S
- Serial Numbers
605 of 605 codes
RTK600014SRTK600015SRTK600023SRTK600024SRTK600026SRTK600027SRTK600028SRTK600029SRTK600030SRTK600031SRTK600032SRTK600033SRTK600034SRTK600035SRTK600037SRTK600038SRTK600039SRTK600041SRTK600042SRTK600043SRTK600044SRTK600045SRTK600048SRTK600050SRTK600051SRTK600052SRTK600053SRTK600054SRTK600055SRTK600056SRTK600057SRTK600058SRTK600059SRTK600060SRTK600061SRTK600062SRTK600063SRTK600064SRTK600065SRTK600066SRTK600067SRTK600068SRTK600070SRTK600071SRTK600072SRTK600073SRTK600082SRTK600083SRTK600084SRTK600085SRTK600086SRTK600087SRTK600088SRTK600089SRTK600092SRTK600093SRTK600094SRTK600095SRTK600096SRTK600097S
- DTPB2Q1GTIN 00763000178185
- Serial Numbers
139 of 139 codes
RTL600106SRTL600179SRTL600278SRTL600345SRTL600518SRTL600524SRTL600756SRTL600786SRTL600788SRTL600802SRTL600845SRTL600979SRTL601099SRTL601105SRTL601116SRTL601128SRTL601131SRTL601166SRTL601169SRTL601177SRTL601196SRTL601199SRTL601242SRTL601250SRTL601284SRTL601316SRTL601322SRTL601325SRTL601326SRTL601339SRTL601344SRTL601345SRTL601364SRTL601368SRTL601386SRTL601391SRTL601402SRTL601408SRTL601410SRTL601423SRTL601424SRTL601427SRTL601432SRTL601439SRTL601440SRTL601474SRTL601478SRTL601480SRTL601482SRTL601488SRTL601490SRTL601491SRTL601495SRTL601507SRTL601536SRTL601549SRTL601554SRTL601574SRTL601576SRTL601585S
- Serial Numbers
86 of 86 codes
RTL600005SRTL600007SRTL600008SRTL600010SRTL600014SRTL600017SRTL600022SRTL600023SRTL600027SRTL600030SRTL600032SRTL600036SRTL600037SRTL600038SRTL600040SRTL600042SRTL600043SRTL600044SRTL600050SRTL600069SRTL600071SRTL600072SRTL600074SRTL600076SRTL600079SRTL600086SRTL600096SRTL600097SRTL600098SRTL600099SRTL600100SRTL600102SRTL600103SRTL600970SRTL600973SRTL600981SRTL600984SRTL600993SRTL601004SRTL601018SRTL601028SRTL601037SRTL601043SRTL601047SRTL601285SRTL601447SRTL601448SRTL601479SRTL601499SRTL601503SRTL601504SRTL601505SRTL601509SRTL601511SRTL601514SRTL601515SRTL601518SRTL601519SRTL601521SRTL601525S
- Amount recalled
- 1408 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Stop using this product now
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.