Reported Aug 17, 2022 · Ongoing
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model…
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?
- Crome Implantable Cardioverter Defibrillators with Cardiac
- Resynchronization Therapy (CRT-D)a. Crome HF CRT-D
- Model Numbers
DTPC2D4DTPC2D1b. Crome HF Quad CRT-D
- Model Numbers
DTPC2QQDTPC2Q1
- Lot codes and dates
- a
- Model NumbersDTPC2D4: GTIN 00763000178291
- Serial Numbers
RTW600120SRTW600307SGTIN 00763000178314
- Serial Numbers
137 of 137 codes
RTW600018SRTW600020SRTW600022SRTW600025SRTW600027SRTW600028SRTW600029SRTW600032SRTW600033SRTW600034SRTW600038SRTW600040SRTW600041SRTW600045SRTW600232SRTW600316SRTW600318SRTW600321SRTW600324SRTW600334SRTW600335SRTW600336SRTW600340SRTW600341SRTW600344SRTW600351SRTW600356SRTW600359SRTW600360SRTW600361SRTW600364SRTW600387SRTW600388SRTW600389SRTW600390SRTW600391SRTW600392SRTW600393SRTW600394SRTW600395SRTW600396SRTW600397SRTW600398SRTW600399SRTW600400SRTW600401SRTW600403SRTW600404SRTW600405SRTW600408SRTW600410SRTW600412SRTW600413SRTW600415SRTW600417SRTW600419SRTW600420SRTW600421SRTW600422SRTW600425S
- DTPC2D1GTIN 00763000178307
- Serial Numbers
RTX600387SRTX600584SRTX600586SRTX600587SRTX600597SGTIN 00763000178321
- Serial Numbers
144 of 144 codes
RTX600014SRTX600015SRTX600016SRTX600018SRTX600022SRTX600025SRTX600027SRTX600028SRTX600029SRTX600030SRTX600034SRTX600035SRTX600088SRTX600163SRTX600179SRTX600202SRTX600231SRTX600243SRTX600247SRTX600249SRTX600251SRTX600252SRTX600258SRTX600262SRTX600268SRTX600269SRTX600278SRTX600286SRTX600463SRTX600464SRTX600466SRTX600467SRTX600471SRTX600472SRTX600474SRTX600475SRTX600476SRTX600477SRTX600478SRTX600482SRTX600483SRTX600484SRTX600485SRTX600486SRTX600487SRTX600490SRTX600491SRTX600492SRTX600493SRTX600494SRTX600495SRTX600500SRTX600501SRTX600502SRTX600503SRTX600505SRTX600506SRTX600507SRTX600508SRTX600509S
- Model NumbersDTPC2QQ: GTIN 00763000178253
- Serial Numbers
RTS600220SRTS600260SRTS600972SGTIN 00763000178277
- Serial Numbers
462 of 462 codes
RTS600014SRTS600015SRTS600016SRTS600017SRTS600018SRTS600020SRTS600022SRTS600024SRTS600026SRTS600027SRTS600029SRTS600030SRTS600031SRTS600032SRTS600034SRTS600035SRTS600036SRTS600037SRTS600038SRTS600039SRTS600041SRTS600042SRTS600043SRTS600044SRTS600045SRTS600048SRTS600050SRTS600051SRTS600053SRTS600055SRTS600056SRTS600058SRTS600060SRTS600061SRTS600063SRTS600064SRTS600066SRTS600069SRTS600228SRTS600235SRTS600274SRTS600275SRTS600281SRTS600284SRTS600286SRTS600292SRTS600293SRTS600295SRTS600296SRTS600300SRTS600301SRTS600302SRTS600303SRTS600304SRTS600305SRTS600306SRTS600308SRTS600309SRTS600310SRTS600311S
- DTPC2Q1GTIN 00763000178260
- Serial Numbers
RTT600423SRTT600424SRTT600434SGTIN 00763000178284
- Serial Numbers
111 of 111 codes
RTT600010SRTT600015SRTT600016SRTT600017SRTT600023SRTT600133SRTT600135SRTT600142SRTT600148SRTT600196SRTT600204SRTT600215SRTT600304SRTT600305SRTT600307SRTT600308SRTT600309SRTT600314SRTT600315SRTT600316SRTT600318SRTT600319SRTT600323SRTT600326SRTT600327SRTT600329SRTT600330SRTT600331SRTT600334SRTT600335SRTT600337SRTT600338SRTT600341SRTT600342SRTT600343SRTT600344SRTT600345SRTT600346SRTT600347SRTT600348SRTT600350SRTT600351SRTT600353SRTT600354SRTT600355SRTT600357SRTT600358SRTT600359SRTT600360SRTT600361SRTT600363SRTT600365SRTT600368SRTT600369SRTT600370SRTT600371SRTT600372SRTT600373SRTT600374SRTT600375S
- Amount recalled
- 866 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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