PROXIMATE TX30VRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705036003335), received between Dec 7, 2017 and Jan 22, 2026 — classified as 5 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (23 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLE LINE DEFORMED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24150468 ↗
• MalfunctionAug 11, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER NOT SEALED REPEATEDLY. SEVERE BLEEDING, HEMOSTASIS BY SURGICAL SPOTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22771093 ↗
• MalfunctionOct 16, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OPERCULUM WHICH TEARS AT THE OPENING: IT WAS IMPOSSIBLE TO MAINTAIN STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463717 ↗
• MalfunctionJun 24, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COMMON BILE DUCT RECONSTRUCTION, WHEN THEY WERE DOING THE SMALL BOWEL ANASTOMOSIS. THEY STAPLED ON THE LAST FIRING AND THEY LEFT A HOLE ON ONE END AND HAD TO OVER SEW. CASE WAS COMPLETED BY OVER SEWING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593107 ↗
• MalfunctionMay 22, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BILATERAL LUNG TRANSPLANT USING THE PROXIMATE LINEAR STAPLER RELOADABLE VASCULAR STAPLER TO GRASP THE LUNG AND USE TO STAPLE; LOCKED ON TISSUE BUT NEVER REOPENED, FORCED TO MANUALLY OPEN THE STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370043 ↗
• MalfunctionMar 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT WHILE USING TX30V, ONCE STAPLING WAS DONE, HCP COULDN'T OPEN THE JAWS ANYMORE. SAID THAT TISSUE WAS STUCK AT THE BOTTOM OF THE ANVIL, BETWEEN ANVIL AND GREY PLASTIC THINGY. THE SURGERY WAS DELAYED BY 30 MINUTES. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960668 ↗
• MalfunctionMar 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT WHILE USING TX30V, ONCE STAPLING WAS DONE, HCP COULDN'T OPEN THE JAWS ANYMORE. SAID THAT TISSUE WAS STUCK AT THE BOTTOM OF THE ANVIL, BETWEEN ANVIL AND GREY PLASTIC THINGY. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960560 ↗
• MalfunctionJan 31, 2024Failure to Form Staple; Premature Separation; Failure to Form Staple; Premature Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER CARTRIDGE LOOSE IN STAPLER, UPON OPENING. STAPLES NOT PROPERLY DEPLOYED AFTER ATTEMPT TO SECURE THEM. SURGERY COMPLETED VIA SUTURING - REPORTED BY DOCTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613990 ↗
• MalfunctionJan 26, 2024Difficult to Insert; Failure to Form Staple; Difficult to Insert; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE UPON OPENING, STAPLER CARTRIDGE FOUND TO BE LOOSE IN STAPLER. STAPLES NOT PROPERLY DEPLOYED AFTER AN ATTEMPT WAS MADE TO SECURE THEM. SURGERY COMPLETED VIA SUTURING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587620 ↗
• InjuryJun 7, 2023Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT PROPERLY CLOSE WHEN PERFORMING THE SUTURE: THE STAPLE MISFITTED AND DID NOT FULFILL ITS FUNCTION. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. IMPORTANT RISK FOR THE PATIENT: EXTENDED HOSPITALIZATION STAY.

  Patient problems: Insufficient Information

  MAUDE report 17078962 ↗
• MalfunctionApr 18, 2023Failure to Fire; Failure to Fire

  SEE ATTACHED USER FACILITY MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762822 ↗
• MalfunctionMar 13, 2023Failure to Fire; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16528991 ↗
• MalfunctionFeb 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT DIDN¿T WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314482 ↗
• MalfunctionNov 21, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, REMOVED FROM THE SURGERY FIELD BECAUSE THE PROCEDURE WAS NOT OPENED DURING THE TEST BEFORE IT WAS USED. FIRED TO OPEN THE APPROXIMATED JAW OUTSIDE THE SURGICAL FIELD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833127 ↗
• MalfunctionNov 16, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON WAS USING THE DEVICE, THE CARTRIDGE WAS NOT FULLY FIRED IN THE PROCESS OF FIRING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805507 ↗
• MalfunctionOct 17, 2022Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER HASN`T MERGE TISSUE COMPLETELY. LEAK OF BLOOD INDICATED IN TWO PART OF TISSUE. NO CONSEQUENCES FOR THE PATIENT REPORTED. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED ANOTHER PRODUCT BY A DIFFERENT MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614697 ↗
• MalfunctionOct 13, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE THAT THE DEVICE DID NOT FIRE. NO FURTHER INFORMATION WAS PROVIDED TO THE SALES REP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595752 ↗
• MalfunctionJul 15, 2022Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A RESPIRATORY SURGERY, THE TISSUE AROUND THE BLOOD VESSELS GOT CAUGHT IN A GROOVE ON THE SIDE OF THE STAPLE, AND THE DEVICE COULD NOT BE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE 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 15032317 ↗
• MalfunctionJul 8, 2022Failure to Fire

  EARLY 50¿S MALE WITH ACUTE APPENDICITIS. PROCEDURE: LAPAROSCOPIC APPENDECTOMY CONVERTED TO OPEN. THE ETHICON STAPLER WOULD NOT FIRE. ANOTHER DEVICE USED. NO KNOWN HARM TO PATIENT THAT WAS DISCHARGED THE NEXT DAY. ====================== MANUFACTURER RESPONSE FOR STAPLE, IMPLANTABLE, PROXIMATE (PER SITE REPORTER). ====================== WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955637 ↗
• MalfunctionMar 9, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A NEPHRECTOMY, THE STAPLER JAMMED DURING USE. THE SURGEON PROCEEDED WITH SUTURING INSTEAD OF STAPLING. THERE WERE NO PATIENT CONSEQUENCES OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709723 ↗
• MalfunctionFeb 24, 2022Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED, THERE WAS AN ARTERIAL BLEED DURING REMOVAL OF MASS AT ILEO-CAECAL JUNCTION (CANINE PATIENT) AND STAPLE FAILED AT THAT POINT (FIRST TIME THEY'D TRIED IT). HEMORRHAGE WAS CONTROLLED BY OTHER MEANS. GA WAS EXTENDED BY MORE THAN 30 MINS BUT OBVIOUSLY AN ART BLEED WILL HAVE HAD AN IMPACT ON THE PATIENT AND LIKELY WAS NOT CONTROLLED AS QUICKLY AS IT WOULD HAVE BEEN WITH STAPLER. SUTURES USED INSTEAD OF STAPLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591432 ↗
• MalfunctionJan 10, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SURGEON COULD NOT OPEN DEVICE AFTER FIRING COMPLETE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206862 ↗
• MalfunctionDec 2, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LOBECTOMY, AFTER RELOADING DEVICE COULD NOT BE FIRED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12918823 ↗
• MalfunctionDec 1, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PNEUMONECTOMY THE DEVICE, WHILE ON THE PULMONARY ARTERY, WOULD NOT OPEN. THEY WERE ABLE TO REMOVE IT WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908017 ↗
• MalfunctionNov 10, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE STAPLE STAYED JAMMED IN THE ANVIL AFTER THE STAPLING. THE SURGEON HAD TO MODIFY HIS OPERATIVE GESTURE, ESPECIALLY CONCERNING THE SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787058 ↗