ASAPLP™ 00884450555125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450555125), received between Oct 20, 2022 and Nov 15, 2022 — classified as 2 injuries.

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

• InjuryNov 15, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING USE IN AN EMERGENCY SURGERY, APPROXIMATELY 20 CENTIMETERS OF THE EXCHANGE LUMEN BROKE OFF WITHIN THE VESSEL OF THE PATIENT. THE PHYSICIAN REMOVED WITH A CAPTURE DEVICE. NO ADDITIONAL INJURY ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801614 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT THE ASPIRATION CATHETER FAILED TO CROSS THE LESION DURING A PRIMARY ANGIOPLASTY IN ACUTE MYOCARDIAL INFARCTION. THE DEVICE WAS REMOVED A NEW DEVICE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638449 ↗