PROXIMATE TX30BRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705036003311), received between Apr 3, 2018 and Apr 16, 2026 — classified as 5 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (10 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A UROLOGICAL PROCEDURE, A TX30B WAS OPENED TO COMPLETE SPECIMEN TRANSECTION DURING AN UROLOGY CASE OVERNIGHT. THE FIRST BLUE WAS FIRED AND THEN A WHITE 30V RELOAD WAS ASKED FOR. THE SURGEON ASKED FOR ADDITIONAL RELOADS AND STAPLERS TO BE OPENED AND ATTEMPTED ONE FIRING ON THE SPECIMEN BEFORE REALIZING THAT THE 30 VASCULAR RELOAD WAS NOT COMPATIBLE WITH THE REGULAR TX HANDLE. IT WAS NOTED UPON PICKING UP THE PRODUCT THAT TWO OF THE WHITE VASCULAR LOADS WERE MISSING THE BOTTOM PLASTIC PIECE THAT KEEPS THE RETAINING PIN IN PLACE. IT WAS THROWN OUT INTRA-OPERATIVELY AFTER THE NURSES TRIED TO REMOVE THE UNFIRED RELOADS FROM THE STAPLER. NO CONSEQUENCE TO THE PATIENT. THE SPECIMEN'S MALFORMED STAPLE LINE WAS OVERSEWED USING SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904183 ↗
• MalfunctionMar 23, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN OPEN LAR, TX30B WAS FIRED. HOWEVER, WHEN LEAK TEST WAS PERFORMED, IT IS FOUND THAT THE STAPLE LINE WAS LOOSE IN THE MIDDLE. SURGEON MENTIONED THAT THE STAPLES DID NOT CAPTURE THE TISSUE FULLY IN THE MIDDLE BUT THERE WERE DOG EARS AT THE SIDE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666875 ↗
• MalfunctionMar 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UROLOGY CASE OVERNIGHT. THE FIRST BLUE WAS FIRED AND THEN A WHITE 30V RELOAD WAS ASKED FOR. THE SURGEON ASKED FOR ADDITIONAL RELOADS AND STAPLERS TO BE OPENED AND ATTEMPTED ONE FIRING ON THE SPECIMEN BEFORE REALIZING THAT THE 30 VASCULAR RELOAD WAS NOT COMPATIBLE WITH THE REGULAR TX HANDLE. IT WAS NOTED UPON PICKING UP THE PRODUCT THAT TWO OF THE WHITE VASCULAR LOADS WERE MISSING THE BOTTOM PLASTIC PIECE THAT KEEPS THE RETAINING PIN IN PLACE. IT WAS THROWN OUT INTRA-OPERATIVELY AFTER THE NURSES TRIED TO REMOVE THE UNFIRED RELOADS FROM THE STAPLER. NO CONSEQUENCE TO THE PATIENT. THE SPECIMEN'S MALFORMED STAPLE LINE WAS OVERSEWED USING SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524363 ↗
• MalfunctionSep 6, 2024Difficult to Insert; No Apparent Adverse Event; Difficult to Insert; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE WHITE VASCULAR WAS DIFFICULT TO LOAD INTO THE TX30B DEVICE. PATIENT EXPERIENCE 1500 CC BLOOD LOSS. SURGERY WAS DELAYED BY HOURS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20162787 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SURGEON HAD TROUBLE DEPLOYING STAPLES USING A PROXIMATE 30MM STAPLER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: HOSPITALIZATION.

  Patient problems: Insufficient Information

  MAUDE report 19032518 ↗
• MalfunctionJan 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE ANY PROCEDURE THERE IS NO SEAL ON THE OUTER CARTON TO TELL ME IF IT WAS PREVIOUSLY OPENED EITHER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455322 ↗
• MalfunctionJan 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE ANY PROCEDURE THERE IS NO SEAL ON THE OUTER CARTON TO TELL ME IF IT WAS PREVIOUSLY OPENED EITHER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455215 ↗
• MalfunctionDec 5, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT STAPLE BEFORE CUTTING. RISK OF BLEEDING. RISK OF INFECTION BY CONTAMINATION BY INTESTINAL MATTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268335 ↗
• MalfunctionNov 1, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CARTRIDGE THAT WAS INITIALLY PRESENT WHEN THE FORCEPS WERE USED WAS INCORRECTLY INSERTED AND THE SURGEON WAS UNABLE TO USE THEM. A NEW REFILL CARTRIDGE HAS BEEN INSTALLED AS A REPLACEMENT, HOWEVER THE STAPLE LINE IS NOT FULLY EXTENDED WHEN THE INSTRUMENT IS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047059 ↗
• InjuryOct 9, 2023Difficult to Insert; Failure to Form Staple; Difficult to Insert; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE RELOAD THAT COMES WITH THE STAPLER WAS NOT INSTALLED PROPERLY AND THE SURGEON COULDN¿T DEPLOY THE STAPLES. A NEW RELOAD WAS INSTALLED BUT WHEN FIRED, THE STAPLES WEREN¿T PROPERLY  B SHAPED . THE SURGEON HAD TO MOBILIZE EXTRA ORGANS AND PROCEEDED WITH AN ILEO-CAECAL RESECTION.

  Patient problems: Insufficient Information

  MAUDE report 17895013 ↗
• MalfunctionMar 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE THAT THE STAPLER WOULD NOT FIRE STAPLE LOADS. 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 16522675 ↗
• MalfunctionAug 2, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT STAPLE WHEN TRIGGERED BECAUSE THERE WAS NO STAPLE INSIDE THE DEVICE, AFTER CHECKING THE ANATOMICAL PIECE AND THE RECTAL STUMP. THEY HAD TO RE-DISSECT THE RECTUM AND MAKE A NEW CUT TO MAKE A NEW STAPLING WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146653 ↗
• MalfunctionJul 29, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY AFTER FIRING ON THE SIGMOID COLON THE EDGE WAS NOT COMPLETELY STAPLED. THEY CLAMPED IT OFF AND GOT A NEW DEVICE. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129179 ↗
• MalfunctionJul 15, 2022Failure to Form Staple; Failure to Fire; No Apparent Adverse Event; Failure to Form Staple; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A UROLOGY PROCEDURE THE STAPLER HAD INCOMPLETE STAPLE FORMATION TO INCLUDE COMPLETELY UNFORMED STAPLES WHERE THE STAPLE LEGS WERE STRAIGHT. THE STAPLE LINE UNRAVELED AND THE LUMEN WAS OPEN. SUTURED CLOSE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027913 ↗
• MalfunctionJan 20, 2022Failure to Form Staple; Failure to Fire; Noise, Audible; Failure to Form Staple; Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE HAD MADE A STRANGE NOISE WHEN STAPLING AND CONSEQUENTLY A BAD STAPLING (DISCONTINUITY OF THE STAPLING LINE) -NOT TIGHT. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310356 ↗
• MalfunctionSep 21, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THORACOTOMY, THE STAPLES DID NOT FORM. THE PROCEDURE WAS COMPLETED WITH A ALTERNATE DEVICE WITH NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560495 ↗
• InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A SLEEVE RESECTION OF THE LEFT LUNG, SURGEON USED A TX30B TO STAPLE THE LEFT MAINSTEM BRONCHUS. DEVICE FIRED AND STAPLES WERE FORMED. AS SURGEON WAS TRANSECTING TISSUE, THE DEVICE POPPED OPEN ON ITS OWN. THIS CAUSED TEARING OF THE PARENCHYMA. SURGEON THEN HAD TO PERFORM A PNEUMONECTOMY.

  Patient problems: Injury

  MAUDE report 10454890 ↗
• MalfunctionMay 14, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE STAPLE LINE WAS INCOMPLETE AFTER STAPLER FIRED. DOCTOR USED SUTURE REINFORCEMENT TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10058628 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE:TITLE: END-TO-END VERSUS END-TO-SIDE STAPLED ANASTOMOSES AFTER ANTERIOR RESECTION FOR RECTAL CANCER. AUTHOR(S): GIUSEPPE BRISINDA, MD, SERAFINO VANELLA, MD,1 FEDERICA CADEDDU, MD, IGNAZIO MASSIMO CIVELLO, MD, FRANCESCO BRANDARA, MD, CASIMIRO NIGRO, MD, PASQUALE MAZZEO, MD, GAIA MARNIGA, MD, AND GIORGIO MARIA, MD. CITATION: J. SURG. ONCOL. 2009;99:75¿79. DOI: 1 0.1002/JSO.21182. THE AIM OF THIS STUDY IS THE EVALUATION OF EARLY AND LATE POSTOPERATIVE COMPLICATIONS IN T1¿T2 RECTAL CANCER PATIENTS WHO UNDERWENT RECTAL RESECTION WITH STAPLED END-TO-END ANASTOMOSIS OR END-TO-SIDE ANASTOMOSIS. POSTOPERATIVE OUTCOMES OF THE TWO PROCEDURES, CLINICOPATHOLOGICAL FEATURES BETWEEN PATIENTS WITH AND WITHOUT ANASTOMOTIC LEAKAGE AND BETWEEN PATIENTS WITH AND WITHOUT ANASTOMOTIC STENOSIS HAVE BEEN COMPARED. BETWEEN JAN 1998 AND JAN 2006, 77 PATIENTS WITH T1¿T2 RECTAL CANCER UNDERWENT RECTAL RESECTION WITH STAPLED ANASTOMOSIS AND WERE DIVIDED BASED ON THE TECHNIQUE OF STAPLED ANASTOMOSIS. IN 37 PATIENTS (20 MALES AND 17 FEMALES, MEAN AGE: 63.7±9.2 YEARS) AN END-TO-END ANASTOMOSIS WAS PERFORMED. IN 40 CASES (19 MALES AND 21 FEMALES, MEAN AGE: 67.0±5.9 YEARS) AN END

  Patient problems: Blood Loss; Failure to Anastomose; Wound Dehiscence

  MAUDE report 9965126 ↗
• MalfunctionFeb 18, 2020Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, STAPLER CARTRIDGE THAT CAME IN STAPLER DID NOT FIRE ANY STAPLES. PACKAGE SAY IT CONTAINS 11 TITANIUM STAPLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9721580 ↗
• MalfunctionFeb 13, 2020Misfire

  (B)(6) 2020. THE STAPLER MISS FIRED, NO STAPLES CAME OUT WHEN FIRED. CAUSED QUITE A BIT OF HASSLE DURING THE CASE, ADDING AN EXTRA 2+ HOURS ON TABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707641 ↗
• InjurySep 16, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCTOCOLECTOMY PROCEDURE, THE STAPLE LINE DID NOT HOLD. SURGEON HAD TO REPAIR/SUTURE THE STAPLE LINE TRANSANALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9071325 ↗
• MalfunctionAug 9, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROSCOPY CONVERTED TO A LAPAROTOMY, IT WAS STATED THAT ONCE CONVERTED THEY RECOGNIZED THE BOWEL HAD PERFORATED, SO THEY USED THE STAPLER TO CLOSE THE PERFORATION. THE STAPLE LINE SHOWED QUESTIONABLE INTEGRITY SO THE SURGEON OVERSEWED THE STAPLE LINE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879244 ↗
• MalfunctionJan 29, 2019Component Missing

  IT WAS REPORTED THAT DURING A SIGMOID RESECTION PROCEDURE, THERE WERE NO STAPLES IN CARTRIDGE. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286720 ↗
• MalfunctionDec 20, 2018Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ¿ITEM FIRING BUT NOT SEALING TISSUE.¿ THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187992 ↗