CPS AIM™ DS2N026-65Recalls & reported problems
St. Jude Medical, Inc. · Slittable Inner Catheter (Subselector) · Class 2
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 05415067005724), received between Oct 4, 2018 and Oct 4, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Separation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2018Break; Separation Problem; Break; Separation Problem
DURING AN IMPLANT PROCEDURE, WHILE REMOVING THE GUIDE CATHETER, THE CATHETER BROKE OFF INSIDE THE PATIENT. THE LEAD WAS REMOVED AND THE GUIDE CATHETER WAS RETRIEVED SUCCESSFULLY. HOWEVER, THE PROCEDURE WAS PROLONGED. THE LEAD WAS REINSERTED SUCCESSFULLY USING A NEW GUIDE CATHETER. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7933612 ↗
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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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