SELECTSITE™ C304XL7405Recalls & reported problems
Medtronic, Inc. · CATHETER C304XL7405 SELECTSITE GLOBAL · Class 2
All models of SELECTSITE (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994729798), received between Apr 4, 2019 and Aug 10, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Accessory Incompatible” (1 report).
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.
Most reported problems
Device problems
- Accessory Incompatible1
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Perforation1
- Pericardial Effusion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2022Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE SLITTER SLIPPED DURING CATHETER SLITTING CAUSING THE LEAD TO DISLODGE. THE CATHETER WAS REPORTED TO BE IN MULTIPLE PIECES. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15201901 ↗MalfunctionMay 23, 2022Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER WAS STIFF IN THE PROXIMAL END AND NOT EASY TO SLIT. THE CATHETER WAS REMOVED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14481603 ↗InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CATHETER USED DURING AN ATTEMPTED CORONARY SINUS CANNULATION, HAD CAUSED CARDIAC PERFORATION AND EFFUSION. THE CATHETER WAS REMOVED AND DISCARDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Cardiac Perforation; Pericardial Effusion
MAUDE report 8483728 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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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