ECHELON ECH60SRecalls & reported problems

Summary

The FDA's MAUDE database contains 631 adverse event reports that list this exact device (DI 10705036035015), received between Feb 17, 2023 and Sep 30, 2026 — classified as 1 death, 56 injuries, 574 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (228 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 631 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50947930 ↗
• MalfunctionSep 28, 2026Positioning Failure; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923848 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923795 ↗
• MalfunctionSep 28, 2026Failure to Fire

  It was reported that, during Video-Assisted Thoracic Surgery for the lung resection, the device could not activate and the knife did not move when the tissue was grasped and fired. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available. r.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920895 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917446 ↗
• MalfunctionSep 28, 2026Failure to Form Staple; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917279 ↗
• MalfunctionSep 25, 2026Difficult to Open or Close

  It was reported that during an Lap Appendectomy, the ECH60S with white reload was was fired and stapled and cut. then hepatics were felt and they could not open jaw, The manual release was used to bring back knife blade and open stapler. No other stapler was needed to complete. There was no patient consequence reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899433 ↗
• MalfunctionSep 25, 2026Failure to Form Staple; No Apparent Adverse Event

  It was reported that during an Unknown surgery, after fired, noted some staples malformed with irregular shape. And then the staple line and cut line are both complete. noted oozing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

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

  MAUDE report 50896166 ↗
• MalfunctionSep 24, 2026Ejection Problem; Separation Problem

  It was reported that during a Nephrectomy procedure, they were able to reload and made a first fire and they took the reload out. And then when they tried to reload again, the reload wasn't sliding down into it. The tech and surgeons tried to do it but they still can't put the reload in so they had to open up another stapler. After the case was over, the sales rep observed the staplers that worked and did not worked. The stapler that did not work looked like there's a piece that was supposed to be beneath another piece that had popped out and was now on top of it on the reload jaw or a metal part of the reload was stuck in the reload jaw, compared to the stapler that worked supposed to be all flat. No patient consequences. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884494 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  It was reported that, during an unknown surgery, the jaws were closed to attach the SLR, but the jaws did not open when the scrub nurse was preparing the device during setting before use. The cartridge color was Gold. 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 50883541 ↗
• MalfunctionSep 21, 2026Difficult to Open or Close; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846140 ↗
• MalfunctionSep 21, 2026Difficult to Open or Close

  It was reported that during a Sleeve Gastrectomy Procedure that while using Echelon 3000 with Staple Line Reinforcement the experienced Surgeon had successfully fired 1x GST60G and 4x GST60B. On the 6th reload scrub loaded GST60B and applied SLR. As the scrub went to open the stapler, and remove the SLR casing, the jaw was stuck together and would not open. The handle opened, but the anvil did not open. They replaced the device and completed the procedure. There were no adverse consequences reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843086 ↗
• MalfunctionSep 21, 2026Unintended Ejection

  It was reported that during an unknown procedure, it was observed that the cartridge was loose and looked like it was moving after loading. There was no effect on the patient. The cartridge color was Green. Another device was used to complete the case. There were no adverse consequences to the patient. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841072 ↗
• MalfunctionSep 21, 2026Mechanical Jam; No Apparent Adverse Event

  It was reported that during a Laparoscopic High Anterior Resection procedure, two firings of the Echelon 3000 (ECH60S) one vascular reload and one gold reload exhibited mild oozing along the staple line after firing. The surgeon commented that she didn't believe that this was supposed to happen. Sales Rep stated that he did not observe anything unusual with the use of the device. However, he did notice that the rotating bezel did not seem to be seated flush with the stapler housing. There was a delay of 20 minutes as the surgeon sutured the bleed on the left colon and applied a clip to the blood vessel that was transected. There was no patient consequence nor surgical delay reported. Additional information requested.

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

  MAUDE report 50840766 ↗
• MalfunctionSep 20, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50834821 ↗
• MalfunctionSep 18, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828953 ↗
• MalfunctionSep 18, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827051 ↗
• MalfunctionSep 18, 2026Noise, Audible

  It was reported that during a Partial Pneumonectomy, the unusual battery sound continued after the stapling was completed. There was no issue with the stapling. There was no effect on the patient. The same device was used as is to complete the case. There were no adverse consequences to the patient. One device will be returning. No cartridge was loaded in the retuned device. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820415 ↗
• InjurySep 17, 2026Failure to Form Staple

  Patient problems: Fibrosis

  MAUDE report 50808678 ↗
• MalfunctionSep 17, 2026Failure to Fire

  It was reported that during an unspecified surgical procedure, it was observed that the blade on the device would not come out during firing. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50804368 ↗
• MalfunctionSep 15, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778208 ↗
• MalfunctionAug 31, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519515 ↗
• MalfunctionAug 31, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519463 ↗
• MalfunctionAug 28, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502167 ↗
• MalfunctionAug 28, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500954 ↗