Proximate PXW35Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10705036002673), received between Apr 24, 2018 and Apr 29, 2026 — classified as 20 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (15 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLERS WERE DEPLOYING STAPLES IN A CROSSED OR MISALIGNED MANNER. AS A RESULT, THE SURGEON WAS UNABLE TO PROPERLY USE THE STAPLERS AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036030 ↗
• MalfunctionApr 29, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE STAPLERS WERE DEPLOYING STAPLES IN A CROSSED OR MISALIGNED MANNER. AS A RESULT, THE SURGEON WAS UNABLE TO PROPERLY USE THE STAPLERS AS INTENDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036013 ↗
• MalfunctionMar 25, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN UNK PROCEDURE THAT THE STAPLER PACKAGE CAME WITH HOLE IN IT - LOSS OF STERILITY COULDN'T BE USED AS INTENDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691203 ↗
• MalfunctionJan 5, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING OPEN PANCREAS SURGERY WHILE CLOSING THE WOUND WITH SKIN STAPLER, THE DEVICE DIDN'T WORK PROPERLY. STAPLERS WERE PLACED KIND OF "UPSIDE DOWN". NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956048 ↗
• InjuryDec 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE A SKIN STAPLE MIGHT HAVE BEEN LEFT INSIDE A PATIENT INTERNALLY. SHE WAS NOT SURE OR DID NOT HAVE THE INFORMATION CURRENTLY IF IT WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23907512 ↗
• InjuryDec 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE A SKIN STAPLE MIGHT HAVE BEEN LEFT INSIDE A PATIENT INTERNALLY. SHE WAS NOT SURE OR DID NOT HAVE THE INFORMATION CURRENTLY IF IT WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23907487 ↗
• MalfunctionOct 15, 2025Mechanics Altered; Firing Problem; Mechanics Altered; Firing Problem

  IT WAS REPORTED THAT DURING A VASCULAR PROCEDURE, THE DEVICE NOT FIRING ALL THE STAPLERS AND THE STAPLERS ARE NOT FORMING CORRECTLY. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278650 ↗
• MalfunctionOct 15, 2025Mechanics Altered; Firing Problem; Mechanics Altered; Firing Problem

  IT WAS REPORTED THAT DURING A VASCULAR PROCEDURE, THE DEVICE NOT FIRING ALL THE STAPLERS AND THE STAPLERS ARE NOT FORMING CORRECTLY. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278005 ↗
• MalfunctionJun 16, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS NOT STAPLING CORRECTLY. NOT FORMING B FORMATION STAPES. ADVERSE IMPACT PATIENT/USER: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210364 ↗
• MalfunctionMay 1, 2025Mechanics Altered; Firing Problem; Mechanics Altered; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN NEUROSURGERY, THE DEVICE COULD NOT BE DEPLOYED AND THE STAPLE WAS UNFORMED WHEN TRIED TO DEPLOY THE STAPLES. ANOTHER COMPETITIVE 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 21941572 ↗
• InjuryApr 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST OP TO A LACERATION CLOSURE THE SURGEON THAT THE PATIENT SHOWED UP IN ED (B)(6) WITH A SCALP LACERATION. LACERATION WAS REPAIRED WITH 3 STAPLES FROM PXW35. PATIENT RETURNED YESTERDAY (B)(6) TO HAVE THE STAPLES AND THE STAPLES WERE NO LONGER VISIBLE. X-RAY CONFIRMED THEY WERE STILL PRESENT AND HAD FULLY LOOPED AS THE SHOULD. PATIENT WENT TO THE OPERATING ROOM FOR REMOVAL AND AFTER THE WOUND WAS RE-OPENED IT WAS DISCOVERED THAT ALL 3 STAPLES WERE EMBEDDED IN THE SKULL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21900528 ↗
• MalfunctionMar 18, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED BY A SALES REP THAT, DURING A LAPAROSCOPIC SIGMOIDECTOMY, MALFORMATION WAS FOUND THAT IT WAS DEPLOYED AND SLID SIDEWAYS WHEN USED THE PRODUCT. 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 21633502 ↗
• InjuryOct 3, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT EXPERIENCED THAT THE WOUND APPROXIMATION IS NOT SO TIGHTLY CLOSED, AND THAT THE WOUND BURSTS MORE THAN USUAL WHEN THE PATIENT RETURNS FOR CHECKUP. THEY ALSO COMPLAINED THAT THEY HAVE TO CHANGE STAPLES AND THAT DON'T ADHERE WELL ENOUGH.

  Patient problems: Wound Dehiscence

  MAUDE report 20360740 ↗
• InjuryOct 3, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT EXPERIENCED THAT THE WOUND APPROXIMATION IS NOT SO TIGHTLY CLOSED, AND THAT THE WOUND BURSTS MORE THAN USUAL WHEN THE PATIENT RETURNS FOR CHECKUP. THEY ALSO COMPLAINED THAT THEY HAVE TO CHANGE STAPLES AND THAT DON'T ADHERE WELL ENOUGH.

  Patient problems: Wound Dehiscence

  MAUDE report 20360704 ↗
• InjuryOct 3, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE THE PATIENT EXPERIENCED THAT THE WOUND APPROXIMATION IS NOT SO TIGHTLY CLOSED, AND THAT THE WOUND BURSTS MORE THAN USUAL WHEN THE PATIENT RETURNS FOR CHECKUP. THEY ALSO COMPLAINED THAT THEY HAVE TO CHANGE STAPLES AND THAT DON'T ADHERE WELL ENOUGH.

  Patient problems: Wound Dehiscence

  MAUDE report 20360547 ↗
• InjuryJul 27, 2023Insufficient Device Problem Information; Firing Problem; Insufficient Device Problem Information; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE PXW35 WAS NOT STAPLING CORRECTLY, JAMMED STAPLES BEING RELEASE AT A TIME WHICH ENDED UP TEARING PATIENT'S SKIN. THERE WAS PATIENT CONSEQUENCE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17404674 ↗
• InjuryNov 1, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE STAPLES WERE NOT FIXED TO THE SKIN. POSE OF STERI-STRIPS. PATIENT HOSPITALIZED FOR CAESAREAN SECTION. THE DAY AFTER THE OPERATION, THE STAPLES DID NOT ATTACH TO THE SKIN.

  Patient problems: Insufficient Information

  MAUDE report 15708304 ↗
• MalfunctionOct 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRE-OP TO THE UNKNOWN PROCEDURE, THE PRODUCT PACKAGING WAS UNSEALED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657616 ↗
• InjuryJun 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2-WEEKS POST-OP FOLLOW-UP THE PATIENT¿S INCISION IS LOOKING INVERTED (SKIN EDGES ARE FOLDING OVER ON EACH OTHER). POOR ALIGNMENT OF STAPLE LINE SKIN CLOSURE. PROCEDURE: SKIN CLOSURE.

  Patient problems: Insufficient Information

  MAUDE report 14743035 ↗
• MalfunctionJun 6, 2022Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES TOOK OFF. THE STAPLES DID NOT HOLD. PASSING THE HAND ON THEM MADE THEM FALL. SURGICAL DELAY. A SUTURE BY THREAD HAD BEEN PERFORMED INSTEAD. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605452 ↗
• InjuryMay 23, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Failure to Eject; Firing Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Failure to Eject; Firing Problem

  IT WAS REPORTED THAT DURING THE CATH LAB PROCEDURE, STAPLER DOES NOT GRAB THE SKIN VERY WELL, SO THE SKIN IS NOT APPROXIMATED. ONE THIRD OF THE TIME THE STAPLE JAMS. THE SURGEON STATED WHEN THEY DO GET IT TO WORK AND GRAB THE SKIN, THEN HALF OF TIME, IT DOESN'T RELEASE EASILY. THEY WOULD OPEN MULTIPLE DEVICES UNTIL THEY GOT ENOUGH STAPLES TO CLOSE THE SKIN. THERE WAS EXTRA BLOOD LOSS. THE PROCEDURE WAS COMPLETED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14470249 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A PIECE OF METAL CAME OUT OF THE STAPLER. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14217979 ↗
• MalfunctionJun 16, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT THE PHYSICIAN USED SKIN STAPLER PXW35 ON A PATIENT TO CLOSE THE ABDOMINAL INCISION. WHEN THE DOCTOR HAD PATIENT COME BACK FOR CHECK UP HE PULLED DRESSING OFF AND THE STAPLES WERE OFF THE PATIENT AND THE INCISION WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007856 ↗
• MalfunctionJan 31, 2020Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS BROKEN OFF AT THE FIRST FIRING. 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 9652740 ↗
• MalfunctionMay 16, 2019Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ONLY THING WRONG WITH THIS ITEM WAS THAT THE PACKAGING HAD A HOLE IN IT. AS IT COULD NO LONGER BE CONSIDERED STERILE, THE OR COULD NOT USE IT. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615389 ↗