CPS DIRECT™ DS2C005Recalls & reported problems
St. Jude Medical, Inc. · Slittable Outer Guide Catheter · Class 2
All models of CPS DIRECT (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734218238), received between Aug 13, 2024 and Aug 13, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, WHILE INSERTING THE CATHETER, THE CORONARY SINUS WAS DISSECTED. UPON X-RAY EXAMINATION, THE DISSECTION WAS CONFIRMED TO HAVE CAUSED A PERFORATION. THE PHYSICIAN ATTEMPTED TO IMPLANT THE LEFT VENTRICULAR LEAD AND WAS UNSUCCESSFUL. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Cardiac Perforation; Vascular Dissection
MAUDE report 19972731 ↗
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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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