PROXIMATERecalls & reported problems across all models

We found 41 models of PROXIMATE by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 2,027 adverse event reports in the FDA's MAUDE database, received between Apr 1, 2013 and Sep 30, 2026 — classified as 22 deaths, 585 injuries, 1,420 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (572 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PROXIMATE problems

PROXIMATE models

41 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PROXIMATE TLC75

  STAPLE, IMPLANTABLE
  14 deaths507 reports
• Proximate PPH03

  STAPLE, IMPLANTABLE
  389 reports
• PROXIMATE TX60B

  STAPLE, IMPLANTABLE
  3 deaths171 reports
• PROXIMATE TCR75

  STAPLE, IMPLANTABLE
  142 reports
• Proximate PMW35

  STAPLE, REMOVABLE (SKIN)
  131 reports
• PROXIMATE TLC10

  STAPLE, IMPLANTABLE
  1 death98 reports
• Proximate PPH01

  STAPLE, IMPLANTABLE
  96 reports
• PROXIMATE TX30V

  STAPLE, IMPLANTABLE
  63 reports
• PROXIMATE TX60G

  STAPLE, IMPLANTABLE
  45 reports
• Proximate TCR10

  STAPLE, IMPLANTABLE
  43 reports
• PROXIMATE TLC55

  STAPLE, IMPLANTABLE
  41 reports
• PROXIMATE TX30G

  STAPLE, IMPLANTABLE
  39 reports
• Proximate PXW35

  STAPLE, REMOVABLE (SKIN)
  37 reports
• PROXIMATE TX30B

  STAPLE, IMPLANTABLE
  27 reports
• Proximate PRW35

  STAPLE, REMOVABLE (SKIN)
  20 reports
• PROXIMATE TCT75

  STAPLE, IMPLANTABLE
  20 reports
• PROXIMATE XR30V

  STAPLE, IMPLANTABLE
  3 deaths20 reports
• PROXIMATE TCR55

  STAPLE, IMPLANTABLE
  18 reports
• PROXIMATE TLH30

  STAPLE, IMPLANTABLE
  1 death17 reports
• PROXIMATE TL90

  STAPLE, IMPLANTABLE
  15 reports
• PROXIMATE TRT10

  STAPLE, IMPLANTABLE
  14 reports
• PROXIMATE TL60

  STAPLE, IMPLANTABLE
  10 reports
• Proximate TCT10

  STAPLE, IMPLANTABLE
  9 reports
• PROXIMATE TLH90

  STAPLE, IMPLANTABLE
  8 reports
• PROXIMATE TLH60

  STAPLE, IMPLANTABLE
  7 reports
• PROXIMATE TVC55

  STAPLE, IMPLANTABLE
  6 reports
• PROXIMATE XR60B

  STAPLE, IMPLANTABLE
  6 reports
• PROXIMATE TL30

  STAPLE, IMPLANTABLE
  4 reports
• PROXIMATE TRT75

  STAPLE, IMPLANTABLE
  4 reports
• PROXIMATE TRD75

  STAPLE, IMPLANTABLE
  3 reports
• PROXIMATE XR30G

  STAPLE, IMPLANTABLE
  3 reports
• Proximate TCD75

  STAPLE, IMPLANTABLE
  2 reports
• PROXIMATE TVR55

  STAPLE, IMPLANTABLE
  2 reports
• PROXIMATE XR30B

  STAPLE, IMPLANTABLE
  2 reports
• PROXIMATE XR60G

  STAPLE, IMPLANTABLE
  2 reports
• Proximate PXR35

  STAPLE, REMOVABLE (SKIN)
  1 report
• Proximate TCT55

  STAPLE, IMPLANTABLE
  1 report
• PROXIMATE TLV30

  STAPLE, IMPLANTABLE
  1 report
• PROXIMATE TR30

  STAPLE, IMPLANTABLE
  1 report
• PROXIMATE TR60

  STAPLE, IMPLANTABLE
  1 report
• PROXIMATE TR90

  STAPLE, IMPLANTABLE
  1 report

Recent PROXIMATE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Form Staple; Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946430 ↗
• MalfunctionSep 21, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840738 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  It was reported that during an unknown surgery, the TX60B stapler did not form the staples correctly. Was there any harm to the reported patient or user? No. Was there a significant delay? Yes. How long was it delayed (minutes)? 30-50 minutes, they had to do the anastomosis manually, as the staples were not formed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772686 ↗
• MalfunctionSep 8, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668577 ↗
• MalfunctionAug 12, 2026Failure to Form Staple; No Apparent Adverse Event

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222145 ↗
• InjuryJul 31, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that Postoperatively, a staple line leak was observed. The patient required reoperation, involving the re-transection of the bowel. The anastomosis was re-stapled. The patients stay is extended due to the reoperation. The patient is currently stable.

  Patient problems: Failure to Anastomose

  MAUDE report 50101922 ↗
• InjuryJul 31, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  It was reported that Postoperatively, a staple line leak was observed. The patient required reoperation, involving the re-transection of the bowel. The anastomosis was re-stapled. The patients stay is extended due to the reoperation. The patient is currently stable.

  Patient problems: Failure to Anastomose

  MAUDE report 50101825 ↗
• InjuryJul 7, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED BY THE SALES REP THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE PATIENT¿S LOBE WAS DESCRIBED AS THICK, PREVENTING THE STAPLER FROM CLOSING INITIALLY. THE SURGEON SUBSEQUENTLY FORCED THE DEVICE TO CLOSE AND HELD COMPRESSION FOR TWO MINUTES. UPON FIRING, A LOUD POP WAS HEARD, AND THE KNIFE DID NOT ADVANCE FURTHER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25738995 ↗
• MalfunctionJun 18, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING GASTRECTOMY PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553290 ↗
• MalfunctionJun 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503848 ↗
• MalfunctionJun 15, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503798 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ILEOCECECTOMY PROCEDURE, THE SURGEON CLOSED THE COMMON ENTEROTOMY USING A TX STAPLER. ON POSTOPERATIVE DAY 1, THE PATIENT DEVELOPED A LEAK AND WAS TAKEN BACK TO SURGERY. UPON RE-EXPLORATION, IT WAS OBSERVED THAT THE STAPLED SITE APPEARED COMPLETELY OPEN, MEASURING APPROXIMATELY 3¿4 CM IN LENGTH. THE SURGEON SUSPECTED A POTENTIAL FAILURE OF THE TX STAPLER; HOWEVER, NO ISSUES WERE NOTED WITH THE DEVICE DURING THE INITIAL PROCEDURE.

  Patient problems: Failure to Anastomose

  MAUDE report 25331327 ↗
• MalfunctionMay 25, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLERS DID NOT DEPLOY STAPLES WHEN FIRED. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270385 ↗
• MalfunctionMay 14, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, A PIN FELL OUT FROM THE DEVICE AND DEVICE WAS UNABLE TO BE USED AFTERWARDS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176112 ↗
• MalfunctionMay 5, 2026Structural Problem

  IT WAS REPORTED THAT DURING A SMALL-BOWEL RESECTION, WHEN REMOVING THE INSTRUMENT¿S ORANGE PROTECTIVE COVER, THE STAPLES CAME OUT OF THE CARTRIDGE SPONTANEOUSLY. OPENING AN INDIVIDUAL CARTRIDGE PRODUCED THE SAME PROBLEM: THE STAPLES CAME OUT OF IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083370 ↗

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• ENDOPATH37 models · 2,785 reports
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