Approach G50789Recalls & reported problems
Cook Incorporated · Approach, CTO-25 Micro Wire Guide · Class 2
All models of Approach (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Oct 14, 2024Open, Classified
Devices from the affected device lots have labels that state the incorrect expiration dates.
Z-0499-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Oct 8, 2024Open, Classified
Affected device lots have labels that state the incorrect expiration dates.
Z-0346-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Other Catheter for crossing total occlusions devices
- Crosser iQ XCTO146Bard Peripheral Vascular, Inc. · Catheter for crossing total occlusions157 reports
- Approach G50791Cook Incorporated · Catheter for crossing total occlusions2 recalls15 reports
- Approach G50792Cook Incorporated · Catheter for crossing total occlusions2 recalls7 reports
- Approach G50787Cook Incorporated · Catheter for crossing total occlusions2 recalls2 reports
- Approach G50786Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- Approach G50788Cook Incorporated · Catheter for crossing total occlusions2 recalls1 report
- OUTBACK OTB59120ACordis US Corp. · Catheter for crossing total occlusions82 reports
- Approach G50793Cook Incorporated · Catheter for crossing total occlusions1 recall17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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