Mailman™ H74912120011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729165699), received between Jun 21, 2018 and Nov 12, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH 5104591 THAT REMOVAL DIFFICULTY AND DEVICE DETACHMENT OCCURRED. DURING A PROCEDURE INVOLVING A 300XM MAILMAN GUIDE WIRE, FIVE STENTS WERE PLACED OVERLAPPING FROM THE PROXIMAL THROUGH MID CIRCUMFLEX ARTERY INTO THE FIRST OBTUSE MARGINAL BRANCH (OM). ANGIOGRAPHIC RESULT WAS SATISFACTORY BUT WHILE TRYING TO REMOVE THE MAILMAN, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. A PORTION OF THE WIRE SHEARED OFF AND WAS RETAINED FROM THE OM3 INTO THE PROXIMAL AORTA. MULTIPLE ATTEMPTS WERE MADE TO SNARE AND REMOVE THE WIRE BUT THEY WERE UNSUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12806872 ↗
• InjuryNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). POST ATHERECTOMY AND STENT PLACEMENT, A 300CM MAILMAN GUIDEWIRE WAS ADVANCED TO CONTINUE THE PROCEDURE. WHEN THE WIRE WAS IN THE RCA, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE TIP HAD BROKEN. NO ATTEMPT WAS MADE TO RETRIEVE THE DEVICE FRAGMENT AND THE DETACHED PORTION OF THE DEVICE WAS LEFT IN DISTAL RCA. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12805677 ↗
• InjuryOct 13, 2021Entrapment of Device; Difficult to Remove; Material Split, Cut or Torn; Physical Resistance/Sticking

  A TOTAL OF 5 CX STENTS WERE PLACED (4 OVERLAPPING FROM PROXIMAL THROUGH MID CX AND 1 IN OM3). ANGIOGRAPHIC RESULT WAS SATISFACTORY BUT THERE WAS SIGNIFICANT RESISTANCE IN THE ATTEMPT TO REMOVE THE CORONARY WIRE WHICH SHEARED OFF WITH A PORTION OF THE CORONARY WIRE BEING RETAINED FROM THE OM3 INTO THE PROXIMAL AORTA. MULTIPLE ATTEMPTS TO SNARE AND REMOVE THE WIRE WERE ULTIMATELY UNSUCCESSFUL. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12633071 ↗
• InjuryNov 6, 2018Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). AFTER A NON-BSC GUIDE WIRE CROSSED THE LESION, A 2.5X15MM NON-BSC STENT WAS ADVANCED BUT IT WAS UNABLE TO BE DELIVERED DISTALLY. THE DEVICE WAS REMOVED AND THE WIRE WAS SWITCHED TO A 300 CM ST MAILMAN GUIDE WIRE IN ORDER TO HELP DELIVER THE STENT. THE NON-BSC STENT WAS ADVANCED AND WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE 2.5X12MM CATHETER, IT BECAME STUCK ON THE WIRE. THE PHYSICIANS PULLED ON THE CATHETER AND THE WIRE WAS ALSO STUCK. AS THEY CONTINUED TO PULL, THE WIRE AND THE CATHETER CAME OUT BUT THE TIP OF THE WIRE WAS LEFT IN THE RCA. THE PHYSICIANS DECIDED NOT TO TRY TO REMOVE THE BROKEN WIRE TIP AND LEAVE IT IN THE RCA AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE AND LEFT THE LAB WITHOUT ANY FURTHER INCIDENT. IT WAS FURTHER REPORTED THAT SNARING WAS NOT ATTEMPTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8043279 ↗
• InjuryJun 21, 2018Device Dislodged or Dislocated

  THE INTERVENTIONALIST WAS ATTEMPTING TO PLACE A STENT WITH AN IDENTIFIED LESION WITHIN THE RCA. THERE WAS SIGNIFICANT CALCIFICATION NOTED AND THE PROVIDER WAS UNABLE TO DELIVER THE STENT, SO THE DECISION WAS MADE TO USE THE MAILMAN BUDDY WIRE. THE STENT WAS SUCCESSFULLY DELIVERED TO THE AFFECTED LESION AND DEPLOYED, THE BUDDY WIRE WAS NOTED TO BE TRAPPED BETWEEN THE STENT AND THE VESSEL. THE PROVIDER ATTEMPTED REMOVE THE BUDDY WIRE, BUT IT SHEARED. A PORTION OF THE WIRE REMAINED WITHIN THE PT AND REQUIRED SURGICAL REMOVAL BECAUSE ATTEMPTS TO USE A SNARE WERE UNSUCCESSFUL. THERAPY START DATE: (B)(6) 2018.

  Patient problems: Calcium Deposits/Calcification; Foreign Body In Patient

  MAUDE report 7628826 ↗