PROXIMATE XR60BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705036013464), received between Apr 2, 2020 and Feb 9, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, TA STAPLER DID NOT DEPLOY STAPLES. THERE WAS NO SURGICAL DELAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296777 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT HAD SIGNIFICANT BLEEDING AFTER USING A TLC75 AND A TX60 STAPLER ON THEM. THE SURGEON CERTAINLY KNOWS HOW TO USE THE DEVICES. BLED 3 DAYS POST OP. PATIENT HAD TO BE BROUGHT BACK TO THE OR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21725362 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT HAD SIGNIFICANT BLEEDING AFTER USING A TLC75 AND A TX60 STAPLER ON THEM. THE SURGEON CERTAINLY KNOWS HOW TO USE THE DEVICES. BLED 3 DAYS POST OP. PATIENT HAD TO BE BROUGHT BACK TO THE OR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21722376 ↗
• MalfunctionMay 13, 2024Failure to Fire; Appropriate Device Problem Term/Code Not Available; Failure to Fire; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE NO STAPLES IN THE RELOAD WHEN THE FIRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299663 ↗
• MalfunctionJul 24, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN FIRING THE TX60B, THERE WAS NO STAPLES IN THE RELOAD. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323288 ↗
• MalfunctionApr 2, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PACKAGING WAS IMPERFECT, THE PACKAGE IS OPENED, IT IS NOT UNDER STERILE STATUS. THE STERILITY WAS COMPROMISED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916810 ↗