CPS DIRECT™ DS2C003Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734218214), received between Nov 28, 2018 and Sep 3, 2020 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Vascular Dissection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, A SMALL CORONARY SINUS DISSECTION OCCURRED WHILE PLACING THE CATHETER. NO ADDITIONAL TREATMENT OR INTERVENTION WAS NECESSARY TO RESOLVE THE DISSECTION, AND THE LV LEAD WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Vascular Dissection
MAUDE report 10488841 ↗InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING AN IMPLANT PROCEDURE, THE CATHETER CAUSED A DISSECTION OF THE CORONARY SINUS. THE PATIENT WAS KNOWN TO HAVE A CONDITION WHICH WEAKENED VESSEL STRUCTURE. THE PROCEDURE WAS ABANDONED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 8112186 ↗
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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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