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Rhythmia™ Mapping System
BOSTON SCIENTIFIC CORPORATION · Model M004RH12000 · UDI-DI 08714729842002
DQK
Prescription
10
510(k) clearances
4,441
Adverse events (53 deaths)
124
Recalls
179
Facilities
Description
Breakout Box B In
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | GE Medical Systems Information Technologies Inc | Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charr |
| 2025-09-16 | Spacelabs Healthcare, Ltd. | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm |
| 2025-08-11 | Merge Healthcare, Inc. | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error mes |
| 2025-04-11 | Centerline Biomedical Inc | Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
| 2024-09-05 | Boston Scientific Corporation | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.