POINTER™ Nitinol Guidewire 180418300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333000753), received between Sep 19, 2024 and Sep 19, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 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.

• MalfunctionSep 19, 2024Break; Break

  A DOCTOR REPORTED THAT DURING MANUAL CONFIGURATION OF THE WIRE TIP BY THE USER, PART OF THE WIRE WOUND AS A COIL BECAME DETACHED AT THE TIP OF THE POINTER WIRE AND WAS DRAWN OUT IN LENGTH. THE POINTER WIRE CAN THEREFORE NO LONGER BE USED FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR STATING THE PATIENT WAS NOT AT RISK AT ANY POINT DURING THE PROCEDURE, AS THE POINTER WIRE DID NOT COME INTO DIRECT CONTACT WITH THE PATIENT. THE PATIENT HAD PAD AND THE AIM OF THE TREATMENT WAS TO PROBE AND DILATE THE ARTERY SUPERFICIALIS AND POPLITEAL ARTERY POPLITEA WITH A BALLOON CATHETER (PTA). WHEN CONFIGURING THE POINTER WIRE FOR BETTER AND FASTER PROBING OF THE TARGET VESSEL BY THE TREATING PHYSICIAN WITH HIS FINGERS, THE MICRO WIRE WOUND AS A COIL CAME LOOSE AT THE TIP OF THE POINTER WIRE AND WAS STRETCHED OUT LENGTHWISE. THE POINTER WIRE WAS IMMEDIATELY REMOVED FROM THE STERILE TABLE AND IMMEDIATELY CARRIED OUT OF THE ANGIOGRAPHY FOR LATER RETURN TO ARGON MEDICAL DEVICES. THE PROCEDURE WAS SUCCESSFUL WITH OTHER PRODUCTS FROM THE COMPETITION WITHOUT ANY RESTRICTIONS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261006 ↗
• MalfunctionSep 19, 2024Break; Break

  A DOCTOR REPORTED THAT DURING MANUAL CONFIGURATION OF THE WIRE TIP BY THE USER, PART OF THE WIRE WOUND AS A COIL BECAME DETACHED AT THE TIP OF THE POINTER WIRE AND WAS DRAWN OUT IN LENGTH. THE POINTER WIRE CAN THEREFORE NO LONGER BE USED FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE DOCTOR STATING THE PATIENT WAS NOT AT RISK AT ANY POINT DURING THE PROCEDURE, AS THE POINTER WIRE DID NOT COME INTO DIRECT CONTACT WITH THE PATIENT. THE PATIENT HAD PAD AND THE AIM OF THE TREATMENT WAS TO PROBE AND DILATE THE ARTERY SUPERFICIALIS AND POPLITEAL ARTERY POPLITEA WITH A BALLOON CATHETER (PTA). WHEN CONFIGURING THE POINTER WIRE FOR BETTER AND FASTER PROBING OF THE TARGET VESSEL BY THE TREATING PHYSICIAN WITH HIS FINGERS, THE MICRO WIRE WOUND AS A COIL CAME LOOSE AT THE TIP OF THE POINTER WIRE AND WAS STRETCHED OUT LENGTHWISE. THE POINTER WIRE WAS IMMEDIATELY REMOVED FROM THE STERILE TABLE AND IMMEDIATELY CARRIED OUT OF THE ANGIOGRAPHY FOR LATER RETURN TO ARGON MEDICAL DEVICES. THE PROCEDURE WAS SUCCESSFUL WITH OTHER PRODUCTS FROM THE COMPETITION WITHOUT ANY RESTRICTIONS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260518 ↗