Official recall record
BD Recanalization System, REF: BDRECANSYSTEM
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-14
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00801741202421
- Brand on record
- Bard Peripheral Vascular Inc
What the authority reported
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 required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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All 6 official recall notices naming Bard Peripheral Vascular Inc on this site →
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