CPS™ DS2A006Recalls & reported problems
St. Jude Medical, Inc. · Universal II Slitter · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067046178), received between May 9, 2024 and Aug 14, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Dull, Blunt
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50261113 ↗MalfunctionFeb 6, 2025Dull, Blunt; Adverse Event Without Identified Device or Use Problem; Dull, Blunt; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED THAT THE SLITTER WAS DIFFICULT TO CUT WITH DUE TO FIRST TIME USE AND THE PHYSICIAN DOES NOT ALLEGE A MALFUNCTION ON THE SLITTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323223 ↗InjuryMay 9, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, WHILE ATTEMPTING TO SLIT THE CATHETER, THE PHYSICIAN WAS INJURED BY THE SLITTER. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING FROM THE CUT AND THE FINGER WAS BANDAGED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19280124 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.