CONTOUR CR40BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036001423), received between Nov 26, 2018 and Sep 13, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE WHEN FIRED, KNIFE WAS STUCK IN THE MIDDLE. KNIFE AND SURGICAL SITE WAS REPAIRED WITH NEW RELOAD AND DEVICE TO FINISH SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736372 ↗
• MalfunctionApr 17, 2020Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN GASTRIC TUBE FORMATION, A DEVICE LOADING THE CR40B COULD NOT BE FIRED AT THE 2ND FIRING ON THE STOMACH. 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 9972637 ↗
• MalfunctionOct 21, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING A SUPER LOWER ANTERIOR RESECTION, THE STAPLES OF THE CR40B WERE UNFORMED AT THE 2ND FIRING ON THE ORAL SIDE OF THE TISSUE. THE SAME EVENT OCCURRED IN THE CR40G AT THE FIRING ON THE ANUS SIDE THE TISSUE. THE PATIENT WAS OVERWEIGHT, AND THE RECTUM WAS THICK. ADDITIONAL HAND SUTURE WAS PERFORMED TO COMPLETE THE CASE SINCE HARTMANN'S OPERATION WAS SCHEDULED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE IS NO BLEEDING, LEAKAGE OR TISSUE DAMAGE WITH THE PATIENT. THERE IS NO PROBLEM WITH THE PATIENT'S CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213265 ↗
• MalfunctionJan 14, 2019Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS FIRED AND NO STAPLES DEPLOYED. UPON INSPECTION IT WAS NOTED THAT THE RELOAD DID NOT HAVE ANY STAPLES. A SECOND RELOAD WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244062 ↗
• MalfunctionNov 26, 2018Complete Blockage

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IMPOSSIBLE FOR THE SURGEON TO PUT A RELOAD IN THE DEVICE (MECHANISM BLOCKED). ANOTHER DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102288 ↗