ZUCKER™ Temporary Pacing Electrode Catheter 051513PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741011450), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PHYSICIAN FELT THE CATHETER WAS TOO STIFF AND NEARLY PERIPHERAL TO A VESSEL. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE IBC ON (B)(6) 2020, THE CATHETERS WERE TOO STIFF AND WOULD NOT WORK TO USE AT THE NECK. IT WAS NOTED THAT THERE WAS NO PROBLEM IN THE GROIN AREA AND NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11047255 ↗