Home › BOSTON SCIENTIFIC CORPORATION › OffRoad™
OffRoad™
BOSTON SCIENTIFIC CORPORATION · Model H74939202101540 · UDI-DI 08714729891970
PDU
Prescription
10
510(k) clearances
1,370
Adverse events (2 deaths)
7
Recalls
41
Facilities
Description
Positioning Balloon Catheter
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.