RELIANCE 4-FRONTRecalls & reported problems across all models
Boston Scientific Corporation · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5,739
- Deaths reported
- 26
- Injuries reported
- 4,385
- Recalls
- 0
We found 11 models of RELIANCE 4-FRONT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 5,739 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2018 and Sep 30, 2026 — classified as 26 deaths, 4,385 injuries, 1,328 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (866 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported RELIANCE 4-FRONT problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,502
- Device Dislodged or Dislocated866
- High impedance804
- High Capture Threshold733
- Over-Sensing439
- Failure to Capture413
- Signal Artifact/Noise306
- Defective Device279
Patient problems
- No Clinical Signs, Symptoms or Conditions2,332
- Unspecified Infection2,227
- Sepsis424
- No Code Available365
- No Known Impact Or Consequence To Patient144
- Pocket Erosion131
- Cardiac Perforation121
- Perforation120
RELIANCE 4-FRONT models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RELIANCE 4-FRONT™ 0672Permanent defibrillator electrodes13 deaths2,895 reports
- RELIANCE 4-FRONT™ 0673Permanent defibrillator electrodes10 deaths2,173 reports
- RELIANCE 4-FRONT™ 0675Permanent defibrillator electrodes3 deaths301 reports
- RELIANCE 4-FRONT™ 0676Permanent defibrillator electrodes261 reports
- RELIANCE 4-FRONT™ 0662Permanent defibrillator electrodes42 reports
- RELIANCE 4-FRONT™ 0663Permanent defibrillator electrodes28 reports
- RELIANCE 4-FRONT™ 0665Permanent defibrillator electrodes17 reports
- RELIANCE 4-FRONT™ 0636Permanent defibrillator electrodes14 reports
- RELIANCE 4-FRONT™ 0652Permanent defibrillator electrodes4 reports
- RELIANCE 4-FRONT™ 0653Permanent defibrillator electrodes2 reports
- RELIANCE 4-FRONT™ 0650Permanent defibrillator electrodes2 reports
Recent RELIANCE 4-FRONT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50953420 ↗DeathSep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient passed away on (B)(6) 2026. During a routine cardiac resynchronization therapy defibrillator (CRT-D) system implant, the patient experienced cardiac arrest. The cardiac arrest occurred while the left ventricular (LV) lead was being implanted and after this right ventricular (RV) lead was implanted. Backup pacing was provided on this RV lead. Cardiopulmonary resuscitation (CPR) was given to the patient, and the patient experienced ventricular tachycardia (VT) and ventricular fibrillation (VF) several times. The field representative noted the patient was stable after the procedure. It was later reported by the field representative that the patient passed away overnight. It was noted the CRT-D was never implanted in the patient. This RV lead was an attempted implant. No additional adverse patient effects were reported.
Patient problems: Cardiac Arrest; Tachycardia; Ventricular Fibrillation
MAUDE report 50950618 ↗MalfunctionSep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949563 ↗MalfunctionSep 30, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947730 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50941342 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50940072 ↗MalfunctionSep 29, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938703 ↗MalfunctionSep 29, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936104 ↗MalfunctionSep 29, 2026High impedance; Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934815 ↗MalfunctionSep 29, 2026High impedance
It was reported that the implantable cardioverter defibrillator (ICD) and this right ventricular (RV) lead exhibited a high out of range shock impedance measurement at 129 Ohms. The shock impedance was back to baseline and was in normal limits. No other lead measurements were out of range. This RV lead remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933348 ↗InjurySep 29, 2026Insufficient Device Problem Information; High Capture Threshold
It was reported that this right ventricular (RV) lead was surgically abandoned due to an unknown reason. A new RV lead was implanted and remains in service. Additional information is being requested from the field. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932777 ↗MalfunctionSep 29, 2026High impedance
It was reported that this single coil right ventricular (RV) defibrillation lead exhibited a gradual rise in shock impedances that appeared to plateau off to high out-of-range measurements greater than 125 Ohms. Technical Services (TS) discussed troubleshooting options and programming considerations for continued monitoring. This RV lead remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927559 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50923938 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50919971 ↗MalfunctionSep 28, 2026Failure to Read Input Signal; Under-Sensing; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918058 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- FINELINE II EZ Sterox6 models · 5,633 reports
- ENDOTAK RELIANCE G12 models · 5,053 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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