N/A SDH21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036003519), received between Sep 28, 2020 and Sep 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Fire” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K983536); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE TOTAL GASTRECTOMY, AFTER FIRED WITH AUDIBLE FEEDBACK, REMOVED THE DEVICE, THE DONUT WERE COMPLETE AS PHOTO SHOW, BUT NOTED 1/2 TISSUE WITHOUT STAPLES, CHECKED SURGICAL AREA, DID NOT FIND ANY STAPLES. USED SUTURE TO OVERSEW AND THE SURGERY DELAYED ONE AND HALF AN HOUR. THE PATIENT'S CONDITION IS CURRENTLY STABLE. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593203 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983536. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1277-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1275-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1278-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1273-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1271-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1274-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-1268-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1269-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1270-2019 · Apr 11, 2019 · Completed
  Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper m
• Z-1276-2019 · Apr 11, 2019 · Completed
  Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper
• Z-1272-2019 · Apr 11, 2019 · Completed
  Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permi
• Z-0672-2018 · Oct 23, 2017 · Terminated
  Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.