Reported Jul 4, 2018 · Terminated
Unify Assura, Sterile EO, Model #/ Part #
St Jude Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: St Jude Medical Inc. · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
Unify Assura, Sterile EO, Model #/ Part #
12 of 12 products
| # | Product as published |
|---|---|
| 1 | CD3257-40/100042333, 100059944 |
| 2 | CD3257-40Q/100042334, 100059936 |
| 3 | CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828 |
| 4 | CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853 |
| 5 | CD3357-40C/100080408, 100080424, 100083511 |
| 6 | CD3357-40Q/100080419, 100080463, 100083504 |
| 7 | CD3361-40/100078842, 100079211, 100083506, 100096893 |
| 8 | CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625 |
| 9 | CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067 |
| 10 | CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558 |
| 11 | CD3389-40C/100080778 |
| 12 | CD3389-40QC/100080780, 100105489 |
- Lot codes and dates
- Serial #:
3,631 of 3,631 codes
103718210052031042043103563910432181038138105776010430821042007103837010431741035637100433210430521043193101329510064651037200100431410052201006461100644510042931006495100519110052221004302100432910591291005200100644710052141005195100647210064521004307100522810065071040448104200510064801004324100521910043101005206104198110132871006485100645610043091040418104048210371511043051104043110404241038164103816510043081013319
- Serial #:
- Amount recalled
- 65048
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
This product could cause temporary or reversible health problems — stop using it.
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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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