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NA M0062601070Recalls & reported problems

Boston Scientific Corporation · Amplatz Type Renal Dilator · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729005490), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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

  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJul 23, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AMPLATZ RENAL DILATOR WAS DELIVERED AT THE FACILITY ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE ARRIVED AT THE FACILITY, IT WAS NOTED THAT THE SHEATH AND THE DILATOR WAS SLIGHTLY BENT WHICH WAS CONFIRMED BY THE PHOTO SENT BY THE CUSTOMER. MOREOVER, A SUSPICION OF CRACK WAS NOTED ON THE DEVICE STERILE POUCH AND THE STERILITY OF THE PRODUCT HAS BEEN COMPROMISED. THIS WAS FOUND PRIOR TO USE WITH A PATIENT OR PROCEDURE.

    Patient problems: No Patient Involvement

    MAUDE report 8816388 ↗

Other Dilator, catheter devices

All Dilator, catheter devices →

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