Reported Aug 17, 2022 · Ongoing
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, 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 Defibrillatorsa. Crome VR ICD
- Model Numbers
DVPC3D1DVPC3D4b. Crome DR ICD
- Model Numbers
DDPC3D1DDPC3D4
- Lot codes and dates
- a
- Model NumbersDVPC3D1: GTIN 00763000178543
- Serial Numbers
199 of 199 codes
RSG600007SRSG600008SRSG600009SRSG600010SRSG600011SRSG600012SRSG600013SRSG600014SRSG600017SRSG600018SRSG600020SRSG600022SRSG600023SRSG600024SRSG600025SRSG600026SRSG600027SRSG600028SRSG600029SRSG600030SRSG600031SRSG600033SRSG600036SRSG600039SRSG600040SRSG600041SRSG600042SRSG600043SRSG600045SRSG600047SRSG600049SRSG600050SRSG600052SRSG600053SRSG600054SRSG600056SRSG600057SRSG600058SRSG600059SRSG600060SRSG600063SRSG600065SRSG600066SRSG600068SRSG600070SRSG600072SRSG600073SRSG600074SRSG600075SRSG600079SRSG600084SRSG600087SRSG600088SRSG600089SRSG600098SRSG600101SRSG600103SRSG600105SRSG600305SRSG600306S
- DVPC3D4GTIN 00763000178550
- Serial Numbers
RSH600816SRSH600826SRSH600910SRSH600917S GTIN 00763000178567
- Serial Numbers
709 of 709 codes
RSH600006SRSH600008SRSH600009SRSH600011SRSH600012SRSH600015SRSH600016SRSH600017SRSH600018SRSH600019SRSH600020SRSH600021SRSH600023SRSH600024SRSH600025SRSH600027SRSH600028SRSH600029SRSH600030SRSH600032SRSH600033SRSH600034SRSH600035SRSH600185SRSH600190SRSH600200SRSH600202SRSH600206SRSH600209SRSH600210SRSH600212SRSH600213SRSH600214SRSH600217SRSH600226SRSH600227SRSH600233SRSH600237SRSH600242SRSH600243SRSH600244SRSH600245SRSH600246SRSH600247SRSH600248SRSH600252SRSH600254SRSH600255SRSH600256SRSH600269SRSH600270SRSH600271SRSH600272SRSH600273SRSH600279SRSH600283SRSH600324SRSH600354SRSH600355SRSH600357S
- Model NumbersDDPC3D1: GTIN 00763000178413
- Serial Numbers
RSP600136SRSP600141SRSP600386SGTIN 00763000178420
- Serial Numbers
159 of 159 codes
RSP600027SRSP600034SRSP600041SRSP600056SRSP600061SRSP600064SRSP600077SRSP600100SRSP600125SRSP600143SRSP600151SRSP600155SRSP600165SRSP600171SRSP600172SRSP600179SRSP600401SRSP600414SRSP600508SRSP600510SRSP600511SRSP600512SRSP600513SRSP600515SRSP600516SRSP600517SRSP600519SRSP600520SRSP600521SRSP600522SRSP600523SRSP600524SRSP600525SRSP600526SRSP600528SRSP600531SRSP600533SRSP600536SRSP600537SRSP600538SRSP600540SRSP600542SRSP600543SRSP600546SRSP600547SRSP600549SRSP600550SRSP600552SRSP600553SRSP600554SRSP600555SRSP600556SRSP600557SRSP600559SRSP600560SRSP600561SRSP600563SRSP600564SRSP600565SRSP600567S
- DDPC3D4GTIN 00763000178437
- Serial Numbers
RSQ600232SRSQ600677SRSQ600735SRSQ600777SRSQ600783SRSQ600801SRSQ600820SRSQ600824SRSQ600916SRSQ600981SRSQ601103SRSQ601172SGTIN 00763000178444
- Serial Numbers
572 of 572 codes
RSQ600006SRSQ600007SRSQ600008SRSQ600009SRSQ600010SRSQ600011SRSQ600013SRSQ600014SRSQ600015SRSQ600018SRSQ600019SRSQ600020SRSQ600022SRSQ600023SRSQ600024SRSQ600026SRSQ600027SRSQ600030SRSQ600031SRSQ600032SRSQ600034SRSQ600037SRSQ600038SRSQ600039SRSQ600040SRSQ600041SRSQ600042SRSQ600044SRSQ600045SRSQ600046SRSQ600047SRSQ600187SRSQ600189SRSQ600190SRSQ600193SRSQ600196SRSQ600198SRSQ600203SRSQ600206SRSQ600215SRSQ600217SRSQ600230SRSQ600234SRSQ600250SRSQ600260SRSQ600264SRSQ600281SRSQ600287SRSQ600290SRSQ600294SRSQ600295SRSQ600297SRSQ600340SRSQ600364SRSQ600365SRSQ600366SRSQ600367SRSQ600368SRSQ600369SRSQ600370S
- Amount recalled
- 1657 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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