CPS DIRECT™ DS2C002Recalls & 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 05414734218207), received between Mar 7, 2019 and Mar 7, 2019 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE FOR A NEW IMPLANT, WHEN ATTEMPTING TO CANNULATE THE CORONARY SINUS FOR LEAD PLACEMENT, THE PHYSICIAN INSERTED THE CATHETER INTO THE VESSEL, WHEN GLIDING THE SHEATH OVER, MOVEMENT (DEEP BREATHING) AND FORCE FROM THE SHEATH CONTACT CAUSED A CORONARY SINUS DISSECTION. THE PHYSICIAN BELIEVED HE MAY HAVE SELECTED THE WRONG CURVE OF SHEATH. THE LEADS WERE SUCCESSFULLY IMPLANTED AND THE PATIENT WAS MONITORED THROUGHOUT. A SUBSEQUENT ECHOCARDIOGRAM POST PROCEDURE CONFIRMED NO EFFUSION WAS PRESENT. THE PATIENT WAS STABLE WITH NO OTHER COMPLICATIONS.
Patient problems: Vascular Dissection
MAUDE report 8400688 ↗
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- 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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