Myopore Sutureless Myocardial Pacing LeadRecalls & reported problems across all models
Greatbatch Ltd · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 535
- Deaths reported
- 7
- Injuries reported
- 244
- Recalls
- 0
We found 2 models of Myopore Sutureless Myocardial Pacing Lead by Greatbatch Ltd in the FDA's device registry (GUDID). Together they are named in 535 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2015 and Sep 18, 2026 — classified as 7 deaths, 244 injuries, 283 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (116 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 Myopore Sutureless Myocardial Pacing Lead problems
Device problems
- Adverse Event Without Identified Device or Use Problem252
- Failure to Capture116
- High Capture Threshold109
- High impedance25
- Low impedance24
- Fracture21
- Insufficient Device Problem Information15
- Device Dislodged or Dislocated14
Patient problems
- Unspecified Infection189
- No Clinical Signs, Symptoms or Conditions158
- Therapeutic Response, Decreased81
- Sepsis19
- Bacterial Infection18
- No Known Impact Or Consequence To Patient15
- No Information12
- Syncope/Fainting10
Myopore Sutureless Myocardial Pacing Lead models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Myopore® Sutureless Myocardial Pacing Lead 511212Permanent Pacemaker Electrode2 deaths274 reports
- Myopore® Sutureless Myocardial Pacing Lead 511211Permanent Pacemaker Electrode5 deaths261 reports
Recent Myopore Sutureless Myocardial Pacing Lead adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 18, 2026Failure to Capture
Loss of capture was reported. Syncope, Fainting and Loss of Consciousness occurred. New lead was implanted.
Patient problems: Syncope/Fainting
MAUDE report 50818467 ↗InjuryAug 31, 2026Failure to Capture
Patient problems: Syncope/Fainting
MAUDE report 50522780 ↗InjuryAug 21, 2026Failure to Capture; Fracture; Device Sensing Problem; Impedance Problem
Failure of epicardial left ventricular lead was reported. Required urgent implant of new leadless pacemaker. Conductor fracture, impedance change with significant sensing and capture issues were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50378511 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50241498 ↗MalfunctionAug 10, 2026Low impedance; Device Sensing Problem; Material Integrity Problem
It was reported that during the implant procedure, the physician attempted to use this left ventricular (LV) lead. While attempting to use the lead, the sensing was not performing appropriately, the pacing impedances were low out of range, and the lead appeared to be fractured. It was noted when the lead was squeezed together, the sensing was working. The physician opted to complete the procedure with a new lead. No additional adverse patient effects were reported. This LV lead has not been returned for analysis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196758 ↗MalfunctionAug 6, 2026Failure to Capture
Patient problems: Loss of consciousness; No Clinical Signs, Symptoms or Conditions; Syncope/Fainting
MAUDE report 50151164 ↗InjuryAug 3, 2026High Capture Threshold
High thresholds on epicardial left ventricle lead was reported. Lead was capped. This event is related to 2183787-2026-00050.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50123125 ↗MalfunctionJul 10, 2026Low impedance
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT, LESS THAN 200 OHMS. TECHNICAL SERVICES (TS) NOTED THERE WAS NO NOISE RECORDED AND THE DEVICE WAS CAPTURING. TS RECOMMENDED TO CONTINUE TO MONITOR. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25786366 ↗InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS INFECTED. LEAD WAS IMPLANTED, OUT-OF-SERVICE. THIS EVENT IS RELATED TO 2183787-2026-00045.
Patient problems: Unspecified Infection
MAUDE report 25660886 ↗MalfunctionJun 29, 2026Failure to Capture; High Capture Threshold
LEAD SHOWED HIGH THRESHOLD AND LOSING TISSUE CAPTURE. LEAD WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25660523 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
LEAD ERODED THROUGH THE SKIN. PATIENT RECEIVED A NEW DEVICE.
Patient problems: Pocket Erosion
MAUDE report 25642011 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
LEAD WAS ATTEMPTED TO BE IMPLANTED ON THE LEFT VENTRICLE AND WAS ACCIDENTALLY PERFORATED.
Patient problems: Perforation
MAUDE report 25642009 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25405634 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED.
Patient problems: Unspecified Infection
MAUDE report 25405630 ↗
Other Greatbatch Ltd products
All Greatbatch Ltd devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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