CORE DYNAMICS CD775Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20653405046162), received between Dec 17, 2015 and Jun 7, 2016 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2016Component Falling; Device Dislodged or Dislocated

  N/A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5703753 ↗
• MalfunctionJun 7, 2016Detachment Of Device Component

  THE END-USER FACILITY REPORTED THAT DURING USE OF A CD775 CORE ENTRɅ II 5-12MM VALVE/REDUCER IN A LAPAROSCOPIC HERNIA REPAIR, THE VALVE BECOME DISLODGED AND FELL INTO THE PATIENT'S PERITONEAL CAVITY. THE VALVE WAS IMMEDIATELY RETRIEVED AND REMOVED FROM THE PATIENT'S PERITONEAL CAVITY. THE SURGEON REPLACED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AS REPORTED, THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT ANY LONG TERM ADVERSE EFFECT HAS OCCURRED.. THIS HAPPENED IN THREE LAPAROSCOPIC HERNIA REPAIR PROCEDURES ON THREE SEPARATE DAYS (DATES OF ACTUAL EVENTS UNKNOWN). THE DEVICES WERE ALL FROM THE SAME LOT. PER THE REPORTER THE PATIENT DEMOGRAPHICS (AGE, GENDER, WEIGHT) FOR EACH CASE IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5703714 ↗
• MalfunctionJun 7, 2016Component Falling; Device Dislodged or Dislocated

  N/A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5703631 ↗
• MalfunctionMay 10, 2016Component Falling; Device Dislodged or Dislocated

  THE END-USER FACILITY REPORTED THAT DURING USE OF A CD775 CORE ENTREE 5-12MM VALVE/REDUCER IN A LAPAROSCOPIC PROCEDURE, THE INNER PLASTIC VALVE BECOME DISLODGED AND FELL INTO THE PATIENT'S PERITONEAL CAVITY. THE VALVE WAS IMMEDIATELY RETRIEVED AND REMOVED FROM THE PATIENT'S PERITONEAL CAVITY. THE SURGEON REPLACED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AS REPORTED, THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT ANY LONG TERM ADVERSE EFFECT HAS OCCURRED..

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5644559 ↗
• MalfunctionMay 3, 2016Device Dislodged or Dislocated

  THE END-USER FACILITY REPORTED THAT DURING USE OF A CD775 CORE ENTRÉE II 5-12MM VALVE/REDUCER IN A LAPAROSCOPIC PROCEDURE, THE INNER PLASTIC VALVE BECOME DISLODGED AND FELL INTO THE PATIENT'S PERITONEAL CAVITY. THE VALVE WAS IMMEDIATELY RETRIEVED AND REMOVED FROM THE PATIENT'S PERITONEAL CAVITY. THE SURGEON REPLACED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY AS A RESULT OF THE REPORTED EVENT. PATIENT DEMOGRAPHICS REGARDING THIS INCIDENT (AGE, GENDER, WEIGHT) WERE UNAVAILABLE FROM THE END-USER FACILITY. IT WAS ALSO REPORTED THAT THIS SAME INCIDENT OCCURRED AGAIN IN A LAPAROSCOPIC PROCEDURE BY THE SAME SURGEON PROVIDER A WEEK SUBSEQUENT TO THIS REPORTED EVENT (SEE ASSOCIATED MEDWATCH 1320894-2016-00035).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5627976 ↗
• MalfunctionMay 3, 2016Device Dislodged or Dislocated

  THE END-USER FACILITY REPORTED THAT DURING USE OF A CD775 CORE ENTRɅ II 5-12MM VALVE/REDUCER IN A LAPAROSCOPIC PROCEDURE, THE INNER PLASTIC VALVE BECOME DISLODGED AND FELL INTO THE PATIENT'S PERITONEAL CAVITY. THE VALVE WAS IMMEDIATELY RETRIEVED AND REMOVED FROM THE PATIENT'S PERITONEAL CAVITY. THE SURGEON REPLACED THE DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY AS A RESULT OF THE REPORTED EVENT. PATIENT DEMOGRAPHICS REGARDING THIS INCIDENT (AGE, GENDER, WEIGHT) WERE UNAVAILABLE FROM THE END-USER FACILITY. IT WAS ALSO REPORTED THAT THIS SAME INCIDENT OCCURRED EARLIER IN A LAPAROSCOPIC PROCEDURE BY THE SAME SURGEON PROVIDER A WEEK PRIOR TO THIS (SEE ASSOCIATED MEDWATCH 1320894-2016-00036).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5627789 ↗
• MalfunctionDec 17, 2015Gas/Air Leak

  THE END-USER FACILITY REPORTED THAT DURING USE OF A CD775 CORE ENTRɅ II 5-12MM VALVE/REDUCER IN THE SURGERY, WHEN INSUFFLATION GAS LEAKED WAS NOTED. SUBSEQUENTLY, THE DEVICE WAS EXAMINED AND COMPLETE DETACHMENT OF THE MAIN BODY SEAL WAS DETECTED. THERE WAS NO REPORT OF SURGICAL COMPLICATION AND NO REPORT OF THE DETACHED SEAL FELL INTO THE SURGICAL SITE RECEIVED FROM THE USER FACILITY. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. DESPITE MULTIPLE FOLLOW-UP REQUESTS, NO ADDITIONAL INFORMATION RECEIVED IN REGARDS TO THE PATIENT'S DEMOGRAPHIC INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5308294 ↗