CPS AIM™ DS2N030-65Recalls & reported problems
St. Jude Medical, Inc. · Slittable Inner Catheter (Cannulator) · Class 2
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 05415067005786), received between Jun 28, 2019 and Apr 11, 2022 — 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 Perforation2
- Cardiac Tamponade2
- Vascular Dissection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-07634, 2017865-2022-07635, 2017865-2022-07636. IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A PERFORATION RESULTING IN TAMPONADE. THE PHYSICIAN PERFORMED PERICARDIAL DRAIN TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Patient problems: Cardiac Perforation; Cardiac Tamponade
MAUDE report 14079119 ↗InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-07634, 2017865-2022-07635, 2017865-2022-07637. IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A PERFORATION RESULTING IN TAMPONADE. THE PHYSICIAN PERFORMED PERICARDIAL DRAIN TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.
Patient problems: Cardiac Perforation; Cardiac Tamponade
MAUDE report 14079109 ↗InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED DURING AN IMPLANT PROCEDURE IN WHICH AN INNER CATHETER WAS BEING USED. IT WAS NOTED THAT WHILE USING THE CATHETER, THE CORONARY SINUS DISSECTED AND WAS CONFIRMED WITH FLUOROSCOPY IMAGING. THE IMPLANT PROCEDURE WAS TERMINATED AND THE PATIENT WAS NOTED TO BE RECOVERING.
Patient problems: Vascular Dissection
MAUDE report 8745603 ↗
Other CATHETER, PERCUTANEOUS devices
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- 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.
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