SSPC3 Delivery Catheter 9183Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810024671830), received between Jul 5, 2024 and Sep 30, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this accessory guidewire exhibited perforation during procedure. Which possibly caused by the guiding being directed toward the hinge side. This accessory was out of service. No additional adverse patient effects were reported.

  Patient problems: Perforation

  MAUDE report 50945912 ↗
• MalfunctionFeb 22, 2026Material Integrity Problem

  IT WAS REPORTED THAT THIS ACCESSORY GUIDING CATHETER EXHIBITED A CURVE FORMATION FAILURE WHICH MIGHT BE DUE TO HEAT RELATED ANOMALY OR REPEATED REPOSITIONING WHICH THE LEAD COULD NO LONGER BE DIRECTED TANGENT TOWARD THE SEPTUM AND APPEARED UNABLE TO REACH THE SITE WHERE PLACEMENT WAS INITIALLY ATTEMPTED. THIS ACCESSORY WAS OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410961 ↗
• InjuryDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CHECK VALVE COMPONENT OF THIS ACCESSORY GUIDE CATHETER DETACHED AND REMAINED WHEN SECURING THE RIGHT VENTRICULAR LEAD TO THE SUCTION SLEEVE. THE ATTENDING PHYSICIAN VERIFIED THE DETACHED COMPONENT TO BE SIMILAR WITH THE TRANSLUCENT RING SHAPED PART FROM A NEW GUIDE CATHETER. THE INVOLVED RV LEAD DID NOT EXHIBIT LEAD DISLODGEMENT WITH NORMAL LEAD DATA MEASUREMENTS AS REPEATEDLY CHECKED WITH NO SIGNIFICANT CHANGES. THIS ACCESSORY WAS OUT OF SERVICE AND WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23855602 ↗
• MalfunctionJul 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS CATHETER WAS DISCONTINUED TO USE DUE TO HEMOSTASIS VALVE BROKE AND THE BACK FLOW OF BLOOD COULD NOT BE STOPPED. THE LEAD FELL OFF WHILE SLITTING THE CATHETER. PHYSICIAN STATED THAT THE CATHETER'S HEMOSTASIS VALVE WAS STIFFER THAN USUAL SO CUTTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684505 ↗