FDA (Devices) recall action 80212

St Jude Medical Inc. recalled 12 products on 2018-07-04

The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.

Products: 12
Announced: 2018-07-04
Critical: 0
Units: 811,702

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–12 of 12

ModerateFDA (Devices)··2018-07-04
St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update
St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/10004294
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Quadra Assura ICDs for Security Firmware Update
St Jude Medical is recalling 72,673 Quadra Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Implantable Cardiac Devices for Security Firmware Update
St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 600107
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Promote Quadra ICDs for Security Firmware Update
St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
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ModerateFDA (Devices)··2018-07-04
St Jude Medical Recalls Unify ICDs for Security Firmware Update
St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Product
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 1000370
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Quadra Assura MP Implantable Cardiac Devices for Security Update
St Jude Medical is recalling 68,117 Quadra Assura MP implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/
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ModerateFDA (Devices)··2018-07-04
St Jude Medical Recalls Ellipse ICDs for Security Firmware Update
St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
Product
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Unify Quadra ICDs for Security Firmware Update
St Jude Medical is recalling Unify Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Unify Assura ICDs for Security Firmware Update
St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
Product
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Merlin PCS Programmer Firmware for Security
St Jude Medical is releasing new firmware for Merlin PCS programmers to strengthen security against unauthorized access to cardiac devices.
Product
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update
St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.
Product
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD123
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HighFDA (Devices)··2018-07-04
St Jude Medical Recalls High Voltage Implantable Cardiac Devices for Security Firmware
St Jude Medical is releasing new firmware for high voltage implantable cardiac devices to strengthen security against unauthorized access.
Product
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 1
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