Convey 6FConvey LeftBU3.5Recalls & reported problems
PendraCare International B.V. · The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. No(0) side holes in the tip section. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729849865), received between Oct 27, 2016 and Oct 27, 2016 — classified as 1 death.
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.
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathOct 27, 2016
AT THE END OF THE PROCEDURE, WHILE REMOVING THE BALLOON CATHETER, THE GUIDE WIRE AND GUIDING CATHETER A DISSECTION OCCURRED IN THE CORONARY ARTERY. THERE WAS NO FLOW ANYMORE. THE PATIENT COLLAPSED AND NEEDED TO BE REANIMATED. THE PATIENT WAS TRANSFERRED URGENTLY TO A SURGICAL CENTER FOR URGENT SURGERY. THE PATIENT FINALLY DIED OF NEUROLOGICAL DAMAGE AFTER REANIMATION.
MAUDE report 6060019 ↗
Other Catheter, Percutaneous devices
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- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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