PROXIMATE XR30VRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705036013457), received between May 9, 2018 and Aug 6, 2025 — classified as 3 deaths, 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLES NOT COMING OUT. THERE IS NO PROBLEM WITH PATIENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727536 ↗
• DeathApr 24, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT THE RIGHT HEPATIC VEIN WAS STAPLED USING THE TX LINEAR STAPLER. ONCE THE VEIN WAS CUT AFTER STALING A MASSIVE BLEEDING WAS ENCOUNTERED RESULTING IN MAJOR HEMORRHAGE. THE OPERATING CONSULTANT IS QUESTIONING IF THE STAPLER FIRED AS THERE WAS NO EVIDENCE OF A STAPLE LINE ON THE PATIENT VESSEL OR IN THE EXPLANTED LIVER WHEN INSPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21900698 ↗
• DeathApr 24, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT THE RIGHT HEPATIC VEIN WAS STAPLED USING THE TX LINEAR STAPLER. ONCE THE VEIN WAS CUT AFTER STALING A MASSIVE BLEEDING WAS ENCOUNTERED RESULTING IN MAJOR HEMORRHAGE. THE OPERATING CONSULTANT IS QUESTIONING IF THE STAPLER FIRED AS THERE WAS NO EVIDENCE OF A STAPLE LINE ON THE PATIENT VESSEL OR IN THE EXPLANTED LIVER WHEN INSPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21900692 ↗
• DeathApr 24, 2025Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Failure to Fire; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LIVER TRANSPLANT THE RIGHT HEPATIC VEIN WAS STAPLED USING THE TX LINEAR STAPLER. ONCE THE VEIN WAS CUT AFTER STALING A MASSIVE BLEEDING WAS ENCOUNTERED RESULTING IN MAJOR HEMORRHAGE. THE OPERATING CONSULTANT IS QUESTIONING IF THE STAPLER FIRED AS THERE WAS NO EVIDENCE OF A STAPLE LINE ON THE PATIENT VESSEL OR IN THE EXPLANTED LIVER WHEN INSPECTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21900690 ↗
• MalfunctionJun 21, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON COULD NOT FINISH THE FIRING SEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171460 ↗
• MalfunctionNov 1, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COMPLETION PNEUMONECTOMY, THE STAPLE WAS MALFORMED AT 3RD AND 4TH FIRING. THE TIP OF THE STAPLE LINE WAS MALFORMED. THE DEVICE WAS USED ON THE BLOOD VESSELS. ADDITIONAL SUTURE WAS PERFORMED IN CASE AND COMPLETED THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707498 ↗
• MalfunctionNov 1, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COMPLETION PNEUMONECTOMY, THE STAPLE WAS MALFORMED AT 3RD AND 4TH FIRING. THE TIP OF THE STAPLE LINE WAS MALFORMED. THE DEVICE WAS USED ON THE BLOOD VESSELS. ADDITIONAL SUTURE WAS PERFORMED IN CASE AND COMPLETED THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707491 ↗
• MalfunctionOct 31, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE USING THE LINEAR STAPLER THE CARTRIDGE MISFIRED THERE WAS NO B FORMATION, SO ANOTHER GUN WAS USED TO COMPLETE THE SURGERY THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700230 ↗
• MalfunctionSep 8, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER MISFIRED, AND THE STAPLES FELL OUT. NEW RELOAD FIRED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378401 ↗
• MalfunctionJul 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS NOT WORKING WELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233865 ↗
• MalfunctionJul 19, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PROFESSOR TRIED TO USE THE CARTRIDGE AFTER INSTALLING IT, BUT IT DIDN'T WORK. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH A NEW PRODUCT. IT HAD NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12192964 ↗
• MalfunctionJun 25, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING OPEN LOBECTOMY PROCEDURE, PROPER CUTTING WAS NOT ACHIEVED FOR EACH FIRING. AFTER SWITCHING TO NEW PRODUCTS, THE PROBLEM WAS SOLVED. NO HARM ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066970 ↗
• MalfunctionJun 25, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING OPEN LOBECTOMY PROCEDURE, PROPER CUTTING WAS NOT ACHIEVED FOR EACH FIRING. AFTER SWITCHING TO NEW PRODUCTS, THE PROBLEM WAS SOLVED. NO HARM ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066940 ↗
• MalfunctionApr 3, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHILE LOADING THE XR30V IT WAS BROKEN PIECE BY PIECE. IT'S UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9921077 ↗
• MalfunctionDec 13, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CARTRIDGE HAD BEEN BROKEN WHEN REMOVING THE CARTRIDGE. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9468687 ↗
• MalfunctionApr 5, 2019Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN OPERATION, THE JAW OF THE PRODUCT DIDN'T OPEN, SO THE COMPLAINT WAS SUBMITTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487640 ↗
• InjuryMar 22, 2019Misfire

  IT WAS REPORTED THAT DURING A UNKNOWN PROCEDURE, SECOND FIRING OF THE TX30V STAPLER SURGEON FIRED AS NORMAL, NO SOUNDS OR ODD FEELING OF THE DEVICE. AFTER CUTTING AND OPENING STAPLER TO REMOVE DEVICE THE PA IMMEDIATELY BEGAN GUSHING BLOOD AS THOUGH NOTHING HAD STAPLED OR STAPLES HAD IMMEDIATELY COME APART. NO STAPLES WERE NOTED IN THE PATIENT THAT THEY CAN RECALL. THEY WERE ABLE TO STOP THE BLEEDING AND SUTURE THE ¿STAPLE LINE¿ THAT DID NOT EXIST. CLAMPED VESSEL AND HAND SUTURED. THE ¿STUMP¿ OF THE VESSEL WAS QUITE THICK AND VERY SHORT SO PLACEMENT OF ANOTHER STAPLER WOULD NOT HAVE WORKED. PATIENT LOST MINIMAL BLOOD (APPROX 500ML OR LESS DURING THIS INCIDENT). SURGERY WAS DELAYED BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS STABLE AS OF A FEW HOURS AFTERWARDS. SURGEON AND NURSE AFTER CASE TRIED TO FIRE AGAIN THE SAME DEVICE AND RELOAD OUTSIDE THE PATIENT TO SEE IF PERHAPS IT HADN¿T FIRED AND IT HAD ITS SAFETY LOCKOUT ENGAGE AS WOULD NORMALLY OCCUR WITH A PREVIOUSLY FIRED STAPLER. WHEN REP ARRIVED LATER IN THE DAY WE TOOK ANOTHER RELOAD FROM THE SAME LOT/BATCH NUMBER; FIRED IT ON A DEMO DEVICE AND STAPLES FORMED AS INTENDED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE P

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8444660 ↗
• MalfunctionOct 9, 2018Break

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE STAPLER FORMATION WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947361 ↗
• MalfunctionJun 13, 2018Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD OF THE STAPLER DID NOT FORM PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596548 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRING TRIGGER WASN'T AVAILABLE, EVEN THOUGH TISSUE WASN'T THAT THICK (IT WAS A VESSEL). THE SURGEON CHANGED TO ANOTHER CARTRIDGE, AND IT WORKED WELL. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500580 ↗