CPS DIRECT™ 410211Recalls & reported problems
St. Jude Medical, Inc. · PL Peelable 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734207065), received between Jun 18, 2018 and Aug 5, 2021 — classified as 3 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 Problem3
Patient problems
- Cardiac Perforation1
- Ischemic Heart Disease1
- Perforation1
- Pericardial Effusion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IMPLANT PROCEDURE. DURING THE PROCEDURE, AFTER A CATHETER WAS INSERTED INTO THE RIGHT ATRIUM, THE PATIENT EXPERIENCED AN ANGINA. THEREFORE, THE PHYSICIAN ELECTED TO STOP THE PROCEDURE. IT WAS UNSURE IF THE ANGINA WAS RESOLVED. THE PATIENT WAS IN STABLE CONDITION AFTER.
Patient problems: Ischemic Heart Disease
MAUDE report 12284306 ↗InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATION ROOM FOR AN INITIAL IMPLANT. DURING THE PROCEDURE A MULTI-FUNCTIONAL CATHETER WAS USED TO FIND THE CORONARY SINUS VEIN. THE VEIN WAS TOO SMALL, THE PHYSICIAN THEN USED SOME FORCE TO INSERT THE CATHETER AND THAT CAUSED CARDIAC PERFORATION. THE PATIENT WAS UNSTABLE AND THE LEAD WAS NOT USED. THE PATIENT WAS STABLE POST PROCEDURE.
Patient problems: Perforation
MAUDE report 7807380 ↗InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING IMPLANT, THE IMPLANT TOOL PERFORATED THE CARDIAC TISSUE RESULTING IN A PERICARDIAL EFFUSION WHILE IMPLANTING THE LEFT VENTRICULAR (LV) LEAD. A PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EVENT AND THE LV LEAD WAS NOT IMPLANTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.
Patient problems: Cardiac Perforation; Pericardial Effusion
MAUDE report 7611800 ↗
Other Catheter, percutaneous devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page