Durata™ 7120/75Recalls & reported problems
St. Jude Medical, Inc. · Defibrillation Lead · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734502108), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Over-Sensing” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P950022); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Over-Sensing1
- Signal Artifact/Noise1
Patient problems
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2018Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
DURING FOLLOW-UP, INCREASED IMPEDANCE AND NOISE LEADING TO OVERSENSING WERE OBSERVED ON THE DEVICE. THE OVERSENSING LED TO THE DELIVERY OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). NO INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION AND THERE WERE NO ADVERSE CONSEQUENCES.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 8046537 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.
- Z-0660-2016 · Nov 3, 2015 · TerminatedOptisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
- Z-0457-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co
- Z-0458-2012 · Nov 28, 2011 · TerminatedSt. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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