CPS Direct™ DS2C022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067004215), received between Dec 6, 2020 and Dec 15, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANT PROCEDURE. DURING THE PROCEDURE, WHEN INSERTING THE CATHETER, IT WAS NOTED THAT THE PATIENT EXPERIENCED A DISSECTION. NO INTERVENTION WAS PERFORMED TO RESOLVE THE DISSECTION. THE IMPLANT PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: Vascular Dissection

  MAUDE report 18337581 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-11546. IT WAS REPORTED THAT DURING LEAD IMPLANT IN A SMALL LATERAL VEIN, CORONARY SINUS WAS DISSECTED WHEN THE PHYSICIAN ADVANCING THE SHEATH. THE LEAD WAS NOT IMPLANTED AND WAS REPLACED. THE NEW LEAD WAS IMPLANTED IN A LARGE POSTERIOR LATERAL BRANCH. NO PATIENT CONSEQUENCES WERE NOTED. THE PATIENT WAS DISCHARGED.

  Patient problems: Vascular Dissection

  MAUDE report 11464233 ↗
• InjuryDec 6, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED DURING IMPLANT PROCEDURE. UPON FLUOROSCOPY, A PROTRUDING STRUCTURE AT THE TIP OF THE CATHETER WAS CONFIRMED. THE CATHETER WAS TAKEN OUT FROM THE PATIENT AND IT WAS FOUND OUT THAT THE TIP BECAME SPLIT. DUE TO THIS, THE CATHETER MAY HAD BEEN CAUGHT AT OSTIUM OF CORONARY SINUS DURING INSERTION. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 10955923 ↗