ASAPLP™ 00884450329306Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450329306), received between Apr 3, 2020 and Dec 16, 2020 — classified as 2 malfunctions.

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.

• MalfunctionDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING AN EMERGENT STEMI ASPIRATION PROCEDURE, THE INTERVENTIONAL GUIDEWIRE [.014] WAS GETTING CAUGHT AT THE RAPID EXCHANGE PORTION OF AN ASPIRATION CATHETER. THE GUIDEWIRE WAS GETTING SHREDDED [DAMAGED] AND FRAGMENTED/DETACHED WITHIN THE PATIENT. AN ADDITIONAL FOREIGN BODY RETRIEVAL PROCEDURE WAS NECESSARY TO SUCCESSFULLY RETRIEVE THE DETACHED PIECES FROM THIS PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023383 ↗
• MalfunctionApr 3, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION [STEMI] PROCEDURE, THE TIP OF AN ASPIRATION CATHETER [RX LUMEN] DETACHED WITHIN THE PATIENT'S DISTAL RIGHT CORONARY ARTERY [RCA]. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL ACCESS AND HAD NEGOTIATED THE AORTIC ARCH TO SUCCESSFUL CANNULATE AND OPACIFY THE PATIENTS OSTIAL RCA. THE PHYSICIAN BALLOONED THE RCA VESSEL AND THEN INSERTED THE ASPIRATION CATHETER INTO THE POSTERIOR DESCENDING ARTERY [CULPRIT LESION] OF THE DISTAL RCA. [THIS WAS APPRECIATED FROM THE RPO ANGLE] THE ASPIRATION CATHETER BECAME STUCK AT THE DISTAL RCA BIFURCATION. THE PHYSICIAN STATED THAT THE VESSEL HAD SPASM. THE PHYSICIAN ATTEMPTED TO ADMINISTER NITRO AND VERAPAMIL WITH NO SUCCESS. A VASCULAR SNARE DEVISE WAS UNSUCCESSFULLY USED TO RETRIEVE THE DETACHED TIP. AN INTERVENTIONAL PCI BALLOON WAS INSERTED NEXT TO THE DETACHED TIP TO ATTEMPT TO DISLODGE THE CATHETER TIP WITH NO SUCCESS. EVENTUALLY THE PATIENTS RCA WAS COMPLETELY STENTED, AND THE ASPIRATION CATHETER TIP WAS JAILED WITHIN THE TUNICA INTIMA OF THE RCA WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO ICU FOR CONTINUOUS OBSERVATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9920874 ↗