Reported Jun 28, 2023 · Ongoing
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; 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?
CRTD COBALT XT HF QUAD MRI IS4 DF1Model Number DTPA2Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00763000178109
- Lot Serial numbers
1,859 of 1,859 codes
RTD602437SRTD602300SRTD602301SRTD602414SRTD602417SRTD602418SRTD602419SRTD601286SRTD600407SRTD600686SRTD600687SRTD600688SRTD600689SRTD601807SRTD602096SRTD602321SRTD601977SRTD600375SRTD600427SRTD600818SRTD601290SRTD601294SRTD601304SRTD603210SRTD601610SRTD601791SRTD600469SRTD601931SRTD601498SRTD601499SRTD601778SRTD602158SRTD602232SRTD602015SRTD602249SRTD603182SRTD601298SRTD600498SRTD603371SRTD600756SRTD602093SRTD601471SRTD601517SRTD601525SRTD601526SRTD601532SRTD601534SRTD601535SRTD601551SRTD601552SRTD601843SRTD601844SRTD601846SRTD601849SRTD601851SRTD601852SRTD601853SRTD601855SRTD601857SRTD601858S
- Lot Serial Numbers
643 of 643 codes
RTD601030SRTD601582SRTD603556SRTD603330SRTD603661SRTD603443SRTD603664SRTD604305SRTD604222SRTD603092SRTD603933SRTD603136SRTD603711SRTD603725SRTD603732SRTD603755SRTD603756SRTD603762SRTD603763SRTD603765SRTD602188SRTD602731SRTD602475SRTD600343SRTD603115SRTD600595SRTD601178SRTD603132SRTD601066SRTD602144SRTD600441SRTD601205SRTD601624SRTD602163SRTD600347SRTD603504SRTD600602SRTD601867SRTD602483SRTD603114SRTD600337SRTD601256SRTD602760SRTD602187SRTD600342SRTD600553SRTD602441SRTD600245SRTD603050SRTD603023SRTD601388SRTD603131SRTD601378SRTD603031SRTD601879SRTD603039SRTD600858SRTD601033SRTD602171SRTD602433S
- Lot Serial Numbers
169 of 169 codes
RTD600624SRTD602315SRTD602593SRTD602541SRTD602308SRTD602408SRTD600989SRTD601166SRTD602496SRTD602486SRTD602271SRTD602439SRTD601112SRTD602660SRTD602469SRTD603038SRTD601606SRTD602492SRTD601150SRTD602266SRTD601887SRTD602495SRTD602125SRTD601165SRTD602314SRTD601115SRTD601131SRTD602179SRTD602227SRTD602259SRTD602260SRTD602270SRTD601623SRTD602602SRTD600993SRTD601122SRTD603545SRTD602481SRTD601625SRTD602231SRTD601124SRTD602154SRTD602155SRTD600925SRTD602493SRTD601121SRTD601100SRTD601113SRTD602596SRTD601146SRTD600618SRTD601172SRTD601129SRTD603568SRTD602494SRTD603766SRTD601102SRTD600997SRTD602875SRTD601882S
- Amount recalled
- 2669 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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