CORDIS 501613ARecalls & reported problems
Cordis US Corp. · CSI LONG 7F 96CM MP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705032009539), received between Sep 3, 2020 and Sep 3, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Partial Blockage” (3 reports).
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
- Partial Blockage3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 3, 2020Partial Blockage; Partial Blockage
AS REPORTED THE SHEATH OF THE THREE 7F 96CM BIOPSY FORCEPS LONG CATHETER SHEATH INTRODUCER SETS CLOTTED OFF WHILE DOING BIOPSY ON THE PATIENT. THE DEVICES WERE REMOVED AND CONFIRMED THAT ALL THREE DEVICES CLOTTED OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10490595 ↗MalfunctionSep 3, 2020Partial Blockage; Partial Blockage
AS REPORTED THE SHEATH OF THE THREE 7F 96CM BIOPSY FORCEPS LONG CATHETER SHEATH INTRODUCER SETS CLOTTED OFF WHILE DOING BIOPSY ON THE PATIENT. THE DEVICES WERE REMOVED AND CONFIRMED THAT ALL THREE DEVICES CLOTTED OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10490325 ↗MalfunctionSep 3, 2020Partial Blockage; Partial Blockage
AS REPORTED THE SHEATH OF THE THREE 7F 96CM BIOPSY FORCEPS LONG CATHETER SHEATH INTRODUCER SETS CLOTTED OFF WHILE DOING BIOPSY ON THE PATIENT. THE DEVICES WERE REMOVED AND CONFIRMED THAT ALL THREE DEVICES CLOTTED OFF. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10489924 ↗
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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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