Reported Jun 28, 2023 · Ongoing
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; 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 DTMB1Q1 AMPLIA MRI QUAD US DF1Model Number DTMB1Q1Implantable Cardioverter Defibrillators
- Lot codes and dates
- GTIN 00643169837683
- Lot Serial Numbers
1,060 of 1,060 codes
RPU202561HRPU202848HRPU202573HRPU203658HRPU203285HRPU203317HRPU203431HRPU203502HRPU203716HRPU203301HRPU203534HRPU203203HRPU203261HRPU203298HRPU203066HRPU203286HRPU202440HRPU202452HRPU202505HRPU202580HRPU202588HRPU202610HRPU202614HRPU202616HRPU202617HRPU202619HRPU202624HRPU202690HRPU202707HRPU202829HRPU202831HRPU202834HRPU202914HRPU203010HRPU203011HRPU203012HRPU203013HRPU203017HRPU203018HRPU203019HRPU203021HRPU203159HRPU203161HRPU203205HRPU203486HRPU203494HRPU203242HRPU203690HRPU203709HRPU203138HRPU202362HRPU202206HRPU202274HRPU202493HRPU202529HRPU202874HRPU203234HRPU203405HRPU202258HRPU202269H
- Lot Serial Numbers
1,114 of 1,114 codes
RPU600085SRPU600412SRPU600758SRPU600889SRPU601159SRPU601226SRPU601507SRPU601526SRPU600346SRPU600399SRPU600592SRPU600321SRPU600414SRPU600492SRPU600903SRPU600369SRPU600160SRPU601531SRPU601138SRPU600659SRPU601001SRPU601171SRPU601082SRPU601083SRPU601248SRPU601118SRPU600297SRPU600407SRPU600300SRPU600706SRPU600947SRPU601038SRPU601107SRPU601178SRPU601219SRPU601261SRPU601312SRPU601391SRPU600277SRPU600486SRPU600495SRPU600730SRPU600856SRPU600926SRPU600943SRPU600980SRPU601486SRPU601554SRPU600195SRPU600382SRPU600600SRPU600552SRPU600488SRPU600531SRPU600598SRPU600808SRPU600560SRPU600027SRPU600111SRPU601182S
- Amount recalled
- 2173 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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