Reported Jun 28, 2023 · Ongoing
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
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?
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOBModel Number DDBC3D4Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169720381
- Lot Serial Numbers
177 of 177 codes
BWF206541HBWF206448HBWF206403HBWF206382HBWF206552HBWF206320HBWF206323HBWF206420HBWF206376HBWF206458HBWF206459HBWF206430HBWF206453HBWF206359HBWF206478HBWF206333HBWF206365HBWF206370HBWF206557HBWF206599HBWF206607HBWF206551HBWF206367HBWF206396HBWF206421HBWF206554HBWF206355HBWF206461HBWF206604HBWF206371HBWF206373HBWF206374HBWF206378HBWF206380HBWF206381HBWF206383HBWF206387HBWF206388HBWF206390HBWF206449HBWF206473HBWF206474HBWF206475HBWF206500HBWF206526HBWF206527HBWF206528HBWF206529HBWF206535HBWF206563HBWF206565HBWF206567HBWF206568HBWF206573HBWF206574HBWF206575HBWF206597HBWF206598HBWF206175HBWF206419H
- Lot Serial Numbers
1,284 of 1,284 codes
BWF606744SBWF606741SBWF606219SBWF606448SBWF606453SBWF606410SBWF605918SBWF605872SBWF606271SBWF605623SBWF606336SBWF606345SBWF605908SBWF605763SBWF605654SBWF606234SBWF605707SBWF605912SBWF606049SBWF606062SBWF606087SBWF606199SBWF606352SBWF606469SBWF606509SBWF605447SBWF605448SBWF605678SBWF605680SBWF606689SBWF606695SBWF607268SBWF605619SBWF606242SBWF606472SBWF606562SBWF606761SBWF605624SBWF605625SBWF605662SBWF605665SBWF606343SBWF606613SBWF606749SBWF605703SBWF605762SBWF606269SBWF606353SBWF605636SBWF606233SBWF606703SBWF606763SBWF606220SBWF605870SBWF605664SBWF605767SBWF606481SBWF605630SBWF605917SBWF606115S
- Lot Serial numbers
1,247 of 1,247 codes
BWF606855SBWF606721SBWF606825SBWF607821SBWF606879SBWF609295SBWF606865SBWF606936SBWF607044SBWF606657SBWF606776SBWF606778SBWF606779SBWF606783SBWF607025SBWF607308SBWF607372SBWF607624SBWF607827SBWF606853SBWF606874SBWF606854SBWF609815SBWF607736SBWF607989SBWF608784SBWF607899SBWF608521SBWF609015SBWF609341SBWF607037SBWF607206SBWF606710SBWF607814SBWF607819SBWF606671SBWF606797SBWF606877SBWF606909SBWF606716SBWF606859SBWF606860SBWF607375SBWF609071SBWF609072SBWF606719SBWF606828SBWF606918SBWF607052SBWF606715SBWF606784SBWF606826SBWF606827SBWF606985SBWF607029SBWF607030SBWF606578SBWF606656SBWF607036SBWF608785S
- Amount recalled
- 4056 units
This recall covers 120 products
The agency filed one notice per product. You are reading one of them; the other 119 are below.
107 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Using this product could cause serious injury, illness or death — stop using it now.
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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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