CPS DIRECT™ DS2C004Recalls & 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 05414734218221), received between Feb 6, 2019 and Feb 6, 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
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER PLACING THE CATHETER AND ATTEMPTING MULTIPLE APPROACHES DYE WAS FLUSHED TO CHECK THE POSITION. IT WAS THEN IDENTIFIED THAT THE SHEATH WAS OUT OF THE VASCULAR SYSTEM IN THE PLURAL SPACE. THE PATIENT WAS STABLE WITH GOOD BLOOD PRESSURE. THE PATIENT WAS TAKEN TO THE OPERATING THEATER FOR EVALUATION. THE PERFORATION IN THE SUPERIOR VENA CAVA - SVC WAS IDENTIFIED AS MINIMAL; A CHEST TUBE WAS INSERTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OPERATING THEATER IN STABLE CONDITION.
Patient problems: Perforation
MAUDE report 8313664 ↗
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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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