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Cardiac Ablation Percutaneous Catheter
FDA product code LPB · Class 3 · Unknown
530
Registered devices
16,442
Adverse events
21
Recalls
0
510(k) clearances
Devices with this code
Maestro 4000™ Controller — BOSTON SCIENTIFIC CORPORATIONN/A — MEDTRONIC, INC.Celsius — Biosense Webster IncN/A — Biosense Webster IncNA — MEDTRONIC, INC.EZ Steer — Biosense Webster IncINTELLAGEN™ Remote Control Connection Cable (10m) — Stockert GmbHCool Point™ — IRVINE BIOMEDICAL, INC.N/A — MEDTRONIC, INC.Maestro 4000™ Controller — BOSTON SCIENTIFIC CORPORATIONBlazer® II — BOSTON SCIENTIFIC CORPORATIONBlazer® II HTD — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.Freezor® MAX — MEDTRONIC, INC.Celsius — Biosense Webster IncFreezor® MAX — MEDTRONIC, INC.SJM™ — IRVINE BIOMEDICAL, INC.nGEN Generator — Biosense Webster IncBlazer Prime® HTD — BOSTON SCIENTIFIC CORPORATIONNA — MEDTRONIC, INC.INTELLAGEN™ Remote Control Connection Cable (30m) — Stockert GmbHEZ Steer NAV — Biosense Webster IncTHERMOCOOL SMARTTOUCH SF — Biosense Webster IncFreezor® Xtra — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THE |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THE |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THE |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THE |
| 2017-09-06 | Biosense Webster, Inc. | Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THE |
| 2017-06-14 | Biosense Webster, Inc. | Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets. |
| 2015-09-01 | Medtronic Inc. Cardiac Rhythm Disease Management | An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. |
| 2014-10-19 | Biosense Webster, Inc. | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
| 2011-07-07 | Biosense Webster, Inc. | Biosense Webster has initiated a voluntary field notification to all customers that have a Stockert 70 Radio Frequency Generator, to communicate undetected soft |
| 2011-02-10 | St Jude Medical | The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the inco |
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