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~1M
reports analyzed
32
device types
6
detection methods
What you'll know that others don't
2026-03-01 MW5084772 MEDTRONIC EVERA MRI ICD DEVICE MALFUNCTION PT PRESENTED WITH INAPPROPRIATE SHOCKS DURING NORMAL SINUS RHYTHM. DEVICE INTERROGATION REVEALED...
2026-03-01 MW5084891 EDWARDS LIFESCIENCES SAPIEN 3 THV INJURY DURING DEPLOYMENT THE VALVE MIGRATED SUPERIORLY REQUIRING EMERGENT SURGICAL RETRIEVAL. THE PATIENT...
2026-02-28 MW5084650 BOSTON SCIENTIFIC WATCHMAN FLX DEVICE MALFUNCTION POST-IMPLANT IMAGING AT 45 DAYS REVEALED DEVICE EMBOLIZATION TO THE LEFT ATRIAL APPENDAGE...
2026-02-28 MW5084553 ABBOTT GALLANT ICD DEATH THE PATIENT EXPIRED FOLLOWING DEVICE FAILURE TO DELIVER THERAPY DURING A SUSTAINED VENTRICULAR TACHYCARDIA EVENT...
2026-02-27 MW5084401 MEDTRONIC MICRA AV DEVICE MALFUNCTION ELEVATED PACING THRESHOLDS NOTED AT 6-MONTH FOLLOW-UP. THRESHOLD INCREASED FROM 0.5V TO 3.75V...
2026-02-27 MW5084398 BIOTRONIK RIVACOR 7 HF-T INJURY LEAD DISLODGEMENT DETECTED 72 HOURS POST-IMPLANT. CHEST X-RAY CONFIRMED RIGHT VENTRICULAR LEAD TIP IN...
2026-02-26 MW5084220 ABBOTT PORTICO DEVICE MALFUNCTION PARAVALVULAR LEAK GRADED AS MODERATE TO SEVERE ON POST-PROCEDURAL ECHOCARDIOGRAPHY. THE DEVICE WAS...
2026-02-26 MW5084195 BOSTON SCIENTIFIC FARAWAVE INJURY PHRENIC NERVE PALSY OBSERVED FOLLOWING PULSED FIELD ABLATION IN THE RIGHT SUPERIOR PULMONARY VEIN...
2026-02-25 MW5084102 ABIOMED IMPELLA 5.5 DEATH HEMOLYSIS DETECTED 36 HOURS AFTER INSERTION. PLASMA-FREE HEMOGLOBIN EXCEEDED 40 MG/DL. DEVICE REPOSITIONED...
2026-02-25 MW5084088 MEDTRONIC COBALT XT DEVICE MALFUNCTION UNEXPECTED BATTERY DEPLETION REACHING ERI AT 14 MONTHS POST-IMPLANT. PREDICTED LONGEVITY WAS...
2026-02-24 MW5083990 EDWARDS LIFESCIENCES PASCAL ACE INJURY CHORDAL ENTANGLEMENT DURING CLIP DEPLOYMENT RESULTED IN WORSENING MITRAL REGURGITATION FROM...
2026-02-24 MW5083887 SHOCKWAVE MEDICAL C2+ DEVICE MALFUNCTION BALLOON RUPTURE ON THIRD PULSE CYCLE. LITHOTRIPSY CATHETER WITHDRAWN AND REPLACED. PROCEDURE...
Edwards Sapien 3 THV
Edwards Lifesciences · Structural Heart
Disproportionate reporting detected for degradation, calcification, and valve regurgitation compared to peer devices.
0.68
Composite Score
+34%
vs. Baseline
Each signal is scored on statistical evidence and clinical impact. You only see what crosses the threshold.
What we detect
Sudden spikes, caught early
When adverse event volume jumps overnight for a device, you'll know before it becomes a trend.
Trends that build quietly
Gradual increases over weeks or months are easy to miss in raw data. We surface sustained shifts before they escalate.
Devices that stand out from peers
Some devices draw disproportionate reporting compared to similar products. We flag outliers across your portfolio.
New failure modes, as they emerge
When a device generates reports about something it's never been flagged for, that's a signal worth investigating.
See what lands in your inbox
A real example from our most recent detection run.
Claripulse Signal Digest
Mar 1 – Mar 14, 2026
Select Signals
Disproportionate reporting detected for degradation, calcification, and valve regurgitation compared to peer devices in the structural heart category.
Reports trending upward over 4 consecutive months. Recent volume 28% above historical baseline.
Sustained rate shift detected. Reporting frequency increased 65% over baseline since October 2025.
By Category
| Category | Reports | Signals |
| CRM Devices | 412 | 5 |
| Structural Heart | 289 | 3 |
| Ablation | 198 | 2 |
| Coronary | 164 | 1 |
| MCS / Support | 112 | 1 |
This digest analyzes publicly available FDA MAUDE data. It does NOT provide medical advice.
Claripulse · Signal intelligence for medical device safety
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