Premium Multifire TA 010315Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521045965), received between Feb 20, 2018 and Jun 27, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL AORTIC ANEURYSM PROCEDURE, WHILE STAPLING THE AORTA, THE STAPLER WAS UNABLE TO BE RELEASED WHILE CLAMPED CLOSE. DEVICE FORCED OPEN WITH LARGE AMOUNT OF FORCE. THE STAPLE LINE WAS INTACT AND ABLE TO COMPLETE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8741833 ↗
• MalfunctionDec 10, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LEFT PNEUMONECTOMY PROCEDURE, THE INSTRUMENT REMAINED CLOSED ON THE VEIN. THE TISSUE WAS DISSECTED AND ANOTHER STAPLER WAS APPLIED TO BE ABLE TO REMOVE THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8146426 ↗
• MalfunctionMay 17, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LEFT PNEUMONECTOMY, WHILE THEY USED THE DEVICE ON THE SUPERIOR PULMONARY VEIN WITHOUT ANY PROBLEM, THEY PROCEEDED TO APPLY THE INSTRUMENT ON THE SECOND LEFT PULMONARY VEIN & ACTIVATED THE INSTRUMENT. WHEN THEY WANTED TO OPEN IT, THE INSTRUMENT REMAINED CLOSE ON THE VEIN. THEY HAD TO DISSECT THE VEIN TOWARD THE MEDIASTINUM TO APPLY A NEW INSTRUMENT WITHOUT ANY PROBLEM. THEY WERE THE ABLE TO TAKE THE INSTRUMENT OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER THAT. THE INSTRUMENT BEING RETURNED WILL BE IN THE CLOSE POSITION WITH THE VEIN SEGMENT IN IT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 7522212 ↗
• MalfunctionFeb 20, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING AN OPEN THORACOSCOPIC LOBECTOMY PROCEDURE WHEN THE DEVICE APPLIED ON VESSEL, THE DEVICE WAS DIFFICULT/UNABLE TO OPEN. THE DEVICE WOULD NOT OPEN AFTER CLAMPED OVER THE TISSUE. IT WAS REMOVED USING ADDITIONAL TOOL. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE SURGEON TOOK THE INSTRUMENT APART IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7284312 ↗