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URCHIN® HP3500Recalls & reported problems

Medtronic, Inc. · HEART POSITIONER HP3500 URCHIN EVO 26L · Class 1

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 00613994533395), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Tissue Damage1

Recent adverse event reports

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

  • InjuryDec 18, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED AN INADVERTENT MIX-UP INVOLVING THE SUCTION LINE FROM THE URCHIN EVO HEART POSITIONER (SUCTION ON THE URCHIN WAS CLOSE TO 500 MM/HG). THIS RESULTED IN TEARS IN THE PATIENT'S EPICARDIUM. THE PRODUCT WAS USED TO COMPLETE THE CASE. REPAIR WAS DONE DURING THIS ORIGINAL SURGERY. PATIENT STATUS IS RECOVERING AND ADDITIONAL PROCEDURES FOR STENTS AND TAVR ARE PLANNED. ADDITIONAL INFORMATION PROVIDED: ORIGINAL CASE SCHEDULED WAS CABG X 4 WITH AVR. SURGEON ONLY COMPLETED LIMA TO LAD.

    Patient problems: Tissue Damage

    MAUDE report 8173623 ↗

Other stabilizer,heart devices

All stabilizer,heart devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.