Reported Aug 17, 2022 · Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT 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 XT HF CRT-D
- Model Numbers
DTPA2D4DTPA2D1b. Cobalt XT HF Quad CRT-D
- Model Numbers
DTPA2QQDTPA2Q1
- Lot codes and dates
- a
- Model NumbersDTPA2D4: GTIN 00763000178130
- Serial Numbers
RTG600136SRTG600270SRTG601323SRTG601338SRTG601367SRTG601433SRTG601484SRTG601489SRTG601575SRTG601583SRTG601595SRTG601632SRTG601643SRTG601653SRTG601657SRTG601669SRTG601775SRTG601790SRTG601802SRTG601805SRTG601820SRTG601847SRTG601892SRTG601904SRTG601968SRTG602017SRTG602019SRTG602125SRTG602147SRTG602179SRTG602182SRTG602191SRTG602207SRTG602209SRTG602221SRTG602226SRTG602238SRTG602239SRTG602360SRTG602439SRTG602477SRTG602480SRTG602490SRTG602506SRTG602512SRTG602515SRTG602516SRTG602524SRTG602550SRTG602580SRTG602584SGTIN 00763000178154
- Serial Numbers
941 of 941 codes
RTG600028SRTG600029SRTG600030SRTG600033SRTG600036SRTG600037SRTG600040SRTG600048SRTG600049SRTG600054SRTG600055SRTG600056SRTG600059SRTG600060SRTG600061SRTG600062SRTG600063SRTG600064SRTG600065SRTG600066SRTG600067SRTG600068SRTG600069SRTG600070SRTG600071SRTG600072SRTG600073SRTG600074SRTG600075SRTG600076SRTG600077SRTG600079SRTG600081SRTG600082SRTG600083SRTG600085SRTG600086SRTG600087SRTG600089SRTG600090SRTG600091SRTG600092SRTG600095SRTG600096SRTG600097SRTG600098SRTG600099SRTG600100SRTG600101SRTG600104SRTG600105SRTG600106SRTG600107SRTG600108SRTG600110SRTG600111SRTG600112SRTG600113SRTG600114SRTG600115S
- Serial Numbers
184 of 184 codes
RTG600302SRTG600337SRTG600344SRTG600353SRTG600355SRTG600357SRTG600362SRTG600365SRTG600371SRTG600376SRTG600379SRTG600382SRTG600387SRTG600389SRTG600391SRTG600392SRTG600396SRTG600397SRTG600407SRTG600409SRTG600410SRTG600413SRTG600414SRTG600416SRTG600417SRTG600419SRTG600420SRTG600421SRTG600422SRTG600425SRTG600427SRTG600429SRTG600431SRTG600432SRTG600433SRTG600439SRTG600442SRTG600775SRTG600776SRTG600777SRTG600778SRTG600785SRTG600789SRTG600790SRTG600797SRTG600802SRTG600804SRTG600807SRTG600814SRTG600815SRTG600818SRTG600822SRTG600823SRTG600824SRTG600825SRTG600826SRTG600827SRTG600828SRTG600830SRTG600832S
- Serial Numbers
RTG601829SRTG602061SRTG602258SRTG602669SRTG602724S
- DTPA2D1GTIN 00763000178147
- Serial Numbers
RTH600598SRTH601437SRTH601544SRTH601557SRTH601590SRTH601762SRTH601782SRTH601832SRTH601844SRTH602085SRTH602090SRTH602094SRTH602104SRTH602105SRTH602150SRTH602168SRTH602172SRTH602198SRTH602220SRTH602255SRTH602261SRTH602265SRTH602267SRTH602282SRTH602312SRTH602320SGTIN 00763000178161
- Serial Numbers
626 of 626 codes
RTH600013SRTH600014SRTH600015SRTH600016SRTH600021SRTH600030SRTH600031SRTH600032SRTH600033SRTH600034SRTH600035SRTH600036SRTH600037SRTH600039SRTH600041SRTH600042SRTH600044SRTH600046SRTH600048SRTH600049SRTH600051SRTH600052SRTH600054SRTH600055SRTH600056SRTH600058SRTH600059SRTH600061SRTH600062SRTH600063SRTH600064SRTH600065SRTH600066SRTH600071SRTH600072SRTH600073SRTH600075SRTH600078SRTH600079SRTH600080SRTH600083SRTH600085SRTH600086SRTH600087SRTH600090SRTH600276SRTH600283SRTH600299SRTH600328SRTH600344SRTH600374SRTH600442SRTH600526SRTH600531SRTH600539SRTH600571SRTH600575SRTH600691SRTH600693SRTH600695S
- Serial Numbers
246 of 246 codes
RTH600724SRTH600725SRTH600726SRTH600729SRTH600731SRTH600732SRTH600735SRTH600736SRTH600737SRTH600738SRTH600742SRTH600743SRTH600744SRTH600746SRTH600747SRTH600749SRTH600751SRTH600752SRTH600755SRTH600756SRTH600757SRTH600758SRTH600766SRTH600767SRTH600769SRTH600777SRTH600783SRTH600786SRTH600794SRTH600798SRTH600799SRTH600800SRTH600801SRTH600802SRTH600803SRTH600804SRTH600805SRTH600807SRTH600808SRTH600809SRTH600810SRTH600812SRTH600814SRTH600815SRTH600816SRTH600817SRTH600818SRTH600819SRTH600820SRTH600821SRTH600822SRTH600824SRTH600825SRTH600826SRTH600827SRTH600828SRTH600829SRTH600830SRTH600831SRTH600832S
- Serial Numbers
RTH602129SRTH602327SRTH602409Sb
- Model NumbersDTPA2QQ: GTIN 00763000178093
- Serial Numbers
66 of 66 codes
RTC600339SRTC600388SRTC600657SRTC600779SRTC602354SRTC605066SRTC605335SRTC605388SRTC605468SRTC606108SRTC606304SRTC606480SRTC606523SRTC606525SRTC606531SRTC606532SRTC607084SRTC607516SRTC607842SRTC607849SRTC607859SRTC608327SRTC608331SRTC608332SRTC609193SRTC609471SRTC609652SRTC609694SRTC609704SRTC610036SRTC610579SRTC610587SRTC610594SRTC610597SRTC610612SRTC610616SRTC610620SRTC610627SRTC610632SRTC610634SRTC610640SRTC610642SRTC610644SRTC610663SRTC610674SRTC610678SRTC610744SRTC610783SRTC610910SRTC610914SRTC610963SRTC610992SRTC611007SRTC611013SRTC611037SRTC611044SRTC611058SRTC611214SRTC611215SRTC611268S
- Serial Numbers
536 of 536 codes
RTC600048SRTC600050SRTC600053SRTC600055SRTC600056SRTC600057SRTC600058SRTC600059SRTC600060SRTC600061SRTC600062SRTC600063SRTC600064SRTC600065SRTC600066SRTC600067SRTC600068SRTC600069SRTC600070SRTC600071SRTC600072SRTC600073SRTC600074SRTC600075SRTC600076SRTC600077SRTC600078SRTC600079SRTC600080SRTC600081SRTC600082SRTC600083SRTC600085SRTC600087SRTC600093SRTC600094SRTC600095SRTC600096SRTC600098SRTC600099SRTC600100SRTC600101SRTC600102SRTC600103SRTC600104SRTC600105SRTC600106SRTC600107SRTC600108SRTC600109SRTC600110SRTC600111SRTC600112SRTC600113SRTC600114SRTC600115SRTC600116SRTC600117SRTC600118SRTC600119S
- Amount recalled
- 8429 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.
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