Home › Device types › OWQ
Reprocessed Intravascular Ultrasound Catheter
FDA product code OWQ · Class 2 · Cardiovascular
93
Registered devices
266
Adverse events
10
Recalls
31
510(k) clearances
Devices with this code
NA — STERILMED, INC.NES Reprocessed Visions PV .035 Digital IVUS Catheter — NORTH EAST SCIENTIFIC INCN/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.NES Reprocessed Visions PV .018 Digital IVUS Catheter — NORTH EAST SCIENTIFIC INCN/A — INNOVATIVE HEALTH LLCNA — STERILMED, INC.NES Reprocessed .014 Stryker Catheter — NORTH EAST SCIENTIFIC INCMEDLINE — MEDLINE INDUSTRIES, INC.NES Reprocessed Visions PV .035 Digital IVUS Catheter — NORTH EAST SCIENTIFIC INCN/A — INNOVATIVE HEALTH LLCNES Reprocessed .035 Stryker Catheter — NORTH EAST SCIENTIFIC INCN/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.NES Reprocessed Eagle Eye Platinum Short Tip Stryker — NORTH EAST SCIENTIFIC INCNA — STERILMED, INC.NA — STERILMED, INC.N/A — INNOVATIVE HEALTH LLCNA — STERILMED, INC.N/A — STRYKER SUSTAINABILITY SOLUTIONS, INC.NA — STERILMED, INC.Philips Healthcare — STRYKER SUSTAINABILITY SOLUTIONS, INC.NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short Tip — NORTH EAST SCIENTIFIC INCN/A — INNOVATIVE HEALTH LLCMEDLINE — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-22 | Medline Industries, LP | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy |
| 2025-12-22 | Medline Industries, LP | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy |
| 2025-12-22 | Medline Industries, LP | These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, sy |
| 2025-10-08 | Sterilmed, Inc. | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe a |
| 2025-10-08 | Sterilmed, Inc. | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe a |
| 2025-07-31 | Medline Industries, LP | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien |
| 2025-07-31 | Medline Industries, LP | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patien |
| 2021-04-26 | Northeast Scientific Inc. | 510k indicated one (1) reprocessing cycle, product not cleared for additional reprocessing cycles. |
| 2020-03-27 | Stryker Sustainability Solutions | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, |
| 2014-09-24 | STERILMED, INC. | Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnost |
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