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INTELLANAV STABLEPOINT™
BOSTON SCIENTIFIC CORPORATION · Model M004RFSDS9620K20 · UDI-DI 08714729992240
0
510(k) clearances
11,392
Adverse events (347 deaths)
34
Recalls
64
Facilities
Description
Ablation Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 | Abbott | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-02-07 | CardioFocus, Inc. | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
| 2024-10-10 | Boston Scientific Corporation | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk. |
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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.