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Catheter, Intracardiac Mapping, High-Density Array
FDA product code MTD · Class 2 · Cardiovascular
49
Registered devices
1,862
Adverse events
9
Recalls
34
510(k) clearances
Devices with this code
AcQMap — ACUTUS MEDICAL, INC.FIRMap — ABBOTTAdvisor™ HD Grid, Sensor Enabled™ — ST. JUDE MEDICAL, INC.OCTARAY Mapping Catheter — Biosense Webster IncNA — STERILMED, INC.PENTARAY NAV — Biosense Webster IncOCTARAY Mapping Catheter — Biosense Webster IncOptiMap™ Catheter - 60mm — Cortex, Inc.EnSite™ — ST. JUDE MEDICAL, INC.OCTARAY Mapping Catheter — Biosense Webster IncConstellation® — BOSTON SCIENTIFIC CORPORATIONAdvisor™ HD Grid X, Sensor Enabled™ — ST. JUDE MEDICAL, INC.FIRMap — ABBOTTAcQMap — ACUTUS MEDICAL, INC.CARTO 3 System eco Interface Cable — Biosense Webster IncOptiMap™ Catheter - 50mm — Cortex, Inc.OPTRELL Mapping Catheter with TRUEref Technology — Biosense Webster IncECOII — W.H.P.M. INC.NA — STERILMED, INC.OptiMap Catheter - 50mm — Cortex, Inc.FIRMap — ABBOTTPENTARAY NAV — Biosense Webster IncConstellation® — BOSTON SCIENTIFIC CORPORATIONOCTARAY Mapping Catheter — Biosense Webster Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-04-28 | Abbott | Incorrect product labeling. |
| 2020-04-22 | BIOSENSE WEBSTER | Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map. |
| 2017-05-17 | Biosense Webster, Inc. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. |
| 2017-05-17 | Biosense Webster, Inc. | Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves. |
| 2016-04-14 | Biosense Webster, Inc. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this ca |
| 2016-04-14 | Biosense Webster, Inc. | Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this ca |
| 2015-08-12 | Abbott Electrophysiology | The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally |
| 2014-02-20 | Biosense Webster, Inc. | Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster i |
| 2005-02-14 | Boston Scientific | The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events. |
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