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SoundBite® Curving Tool 14
Soundbite Medical Solutions Inc · Model 900-0001291 · UDI-DI 17540265105022
PDU
Prescription
1
510(k) clearances
1,370
Adverse events (2 deaths)
7
Recalls
41
Facilities
Description
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-14 | Bard Peripheral Vascular Inc | Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart require |
| 2020-10-16 | Ra Medical Systems, Inc. | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' po |
| 2020-07-24 | Ra Medical Systems, Inc. | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| 2020-01-23 | Ra Medical Systems, Inc. | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (r |
| 2019-09-19 | Ra Medical Systems, Inc. | The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently les |
| 2018-02-15 | Ra Medical Systems Inc | Lasers/Catheters did not calibrate during set-up prior to use. |
| 2015-07-22 | Volcano Corporation | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Cathe |
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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.