Memory Basket G21538Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002215382), received between Sep 8, 2017 and Jul 20, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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. 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880908 ↗
• MalfunctionJun 16, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER CHECKED THE DEVICE BEFORE USE AND FOUND OUT THE BASKET COULD NOT BE RETRACTED. USER CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526306 ↗
• MalfunctionJun 16, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER DETECTED THE BASKET COULD NOT BE RETRACTED. USER CHANGED TO A NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526279 ↗
• MalfunctionJun 16, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC PROCEDURE, FOR STONE REMOVAL, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT BEFORE USE, USER TESTED THE DEVICE AND FOUND OUT THE BASKET COULD NOT BE RETRACTED INTO SHEATH AFTER ADVANCED OUT. THIS OCCURRED WITH FOUR (4) BASKETS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520681 ↗
• MalfunctionJun 5, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, FOR STONE REMOVAL IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER DETECTED THE BASKET WAS STUCK AND COULD NOT BE RETRACTED. USER RETRACTED THE DEVICE FROM PATIENT AND CHANGED TO A NEW MB5-2X4-8 TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407754 ↗
• MalfunctionMay 22, 2026Difficult to Fold, Unfold or Collapse

  DURING GALLSTONE REMOVAL, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT AFTER SEVERAL USES, THE BASKET COULD NO LONGER BE OPENED OR CLOSED. UPON REMOVAL AND INSPECTION, KINKING WAS OBSERVED IN BOTH THE BASKET PORTION AND THE SHAFT. SUBSEQUENTLY, A NEW BASKET WAS USED, AND THE PROCEDURE WAS COMPLETED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25259996 ↗
• MalfunctionMar 2, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE STONES FROM THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS INITIALLY REPORTED THE NURSE OPENED THE PACKAGING OF THE NEW PRODUCT AND INSPECTED THE BASKET FOR ANY ABNORMALITIES BEFORE INSERTING IT INTO THE SCOPE, AND FOUND NONE. HOWEVER, WHEN THEY POSITIONED THE BASKET INSIDE THE BILE DUCT AND MANIPULATED THE HANDLE, IT DID NOT MOVE. THE BASKET ALSO DID NOT COME OUT OF THE SHEATH. THEREFORE, THEY HAD TO REMOVE THE MB5-2X4-8 FROM THE PATIENT AND USE A NEW MB5-2X4-8. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 06FEB2026 AND THE BASKET WAS FULLY ADVANCED, AND THE BASKET WOULD NOT RETRACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483575 ↗
• MalfunctionFeb 4, 2026Difficult to Fold, Unfold or Collapse

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN SELECTED TWO COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKETS. IT WAS REPORTED THAT BEFORE USING IT ON THE PATIENT, THE OPERATION WAS CHECKED. THE HANDLE MOVED, BUT THE BASKET DID NOT MOVE. THE BASKET IS PACKAGED WITH THE BASKET EXTENDED SO THIS IS INTERPRETED AS UNABLE TO RETRACT THE BASKET. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260775 ↗
• MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS INITIALLY REPORTED THAT WHEN THE NURSE TRIED TO CAPTURE THE STONE, SHE RECOGNIZED THAT THE HANDLE DIDN'T MOVE AT ALL. SO THE PHYSICIAN WITHDREW THE BASKET OUT OF THE SCOPE AND EXCHANGED ANOTHER MB-35 AND FINALLY HE CAPTURED THE BASKET AND FINISHED THIS CASE. THE BASKET WOULD HAVE BEEN RETRACTED TO ADVANCE THE DEVICE THROUGH THE SCOPE SO IF THE HANDLE DID NOT WORK WHILE THE DEVICE WAS IN THE PATIENT THE BASKET WOULD BE RETRACTED AND UNABLE TO ADVANCE. THIS HAS NOT HISTORICALLY CAUSED OR CONTRIBUTED TO SERIOUS INJURY NOR DEATH TO THE PATIENT SO IT WAS CONSIDERED NOT REPORTABLE AT THAT TIME. THE DEVICE RETURNED ON 09JAN2026 AND PER INITIAL QE EVALUATION, "THE BASKET WAS RETURNED FULLY EXTENDED AND THERE WAS KINKING OF THE SHEATH AT THE BASE OF THE HANDLE. THE BASKET WOULD NOT RETRACT AND CAUSED MORE KINKING OF THE SHEATH AT THE BASE OF THE HANDLE." THIS CHANGES THE ASSESSMENT TO UNABLE TO RETRACT THE BASKET AND IS THE SUBJECT OF THIS REPORT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234756 ↗
• MalfunctionJan 29, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, FOR STONE REMOVAL, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER DETECTED THAT THE BASKET COULD NOT BE RETRACTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214707 ↗
• MalfunctionJan 22, 2026Difficult to Fold, Unfold or Collapse

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, FOR STONE REMOVAL, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER DETECTED THAT THE BASKET COULD NOT BE RETRACTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145729 ↗
• MalfunctionDec 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT WHEN THE NURSE TRIED TO PUT BASKET INSIDE THE SHEATH, THE BASKET WAS NOT PUT INSIDE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837214 ↗
• MalfunctionDec 2, 2025Fracture; Fracture

  DURING A PROCEDURE TO REMOVE SANDY STONES, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT AFTER THE PHYSICIAN DEPLOYED THE COMPLAINT PRODUCT, ONE STONE WAS SUCCESSFULLY EXTRACTED. HOWEVER, IT WAS FOUND THAT ONE WIRE OF THE BASKET HAD BROKEN DURING EXTRACTION, MAKING IT UNUSABLE. THE PHYSICIAN THEN OPENED A NEW SET OF THE PRODUCT TO COMPLETE THE STONE REMOVAL PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691681 ↗
• MalfunctionNov 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  DURING PREPARATION FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT WHEN THE NURSE TRIED TO PUT THE BASKET INSIDE THE SHEATH, THE BASKET WAS NOT PUT INSIDE [UNABLE TO RETRACT THE BASKET]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526588 ↗
• MalfunctionOct 22, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE PHYSICIAN TESTED TWO (2) COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE HANDLE DOESN'T MOVE. THIS OCCURRED DURING TESTING; THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360925 ↗
• MalfunctionOct 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IN PREPARATION FOR CBD STONE REMOVAL INSIDE THE BILIARY TRACT, THE PHYSICIAN SELECTED A COOK MEMORY II DOUBLE LUMEN EXTRACTION BASKET. IT WAS REPORTED THAT AFTER REMOVING THE SLEEVE COVERING THE BASKET AND ATTEMPTING TO PULL THE HANDLE TO RETRACT THE BASKET INTO THE SHEATH, THE HANDLE WOULD NOT MOVE. IT COULD NOT BE ADVANCED OR RETRACTED. THIS OCCURRED WITH FOUR (4) DEVICES FROM THE SAME LOT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302741 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT WHEN THE PHYSICIAN INSERTED THE DEVICE INTO THE BILE DUCT AND ATTEMPTED TO OPEN THE BASKET, THE WIRE WAS TORN AND COULDN'T OPEN IT. HE STOPPED USING IT AND CONTINUED THE PROCEDURE WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635952 ↗
• MalfunctionJul 1, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, FOR STONE REMOVAL, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE BASKET COULD NOT BE CLOSED COMPLETELY, THEN RETRACTED THE BASKET AND FOUND OUT THE BASKET WIRE WAS BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371025 ↗
• MalfunctionJun 9, 2025Fracture; Fracture

  DURING A STONE REMOVAL OF PANCREATIC STONES IN THE PANCREAS, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT THE USER ADVANCED THE DEVICE INTO THE TARGET AREA IN PATIENT, OPENED THE BASKET TO CAPTURE THE STONE AND THE BASKET WIRE IMMEDIATELY BROKE. THE USER RETRACTED THE BASKET INTO SHEATH AND OUT OF PATIENT AND CHANGED TO ANOTHER BASKET TO CONTINUE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169238 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS INITIALLY REPORTED THAT IN THE PREPARATORY PHASE OF PROCEDURE, IT WAS FOUND THAT THE BASKET COULD NOT BE TIGHTENED PROPERLY. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. WE RECEIVED ADDITIONAL INFORMATION ON 03 MAR 2025 STATING THAT THE BASKET WOULD NOT RETRACT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718257 ↗
• MalfunctionFeb 4, 2025Fracture; Fracture

  DURING STONE EXTRACTION IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK MEMORY EIGHT WIRE BASKET. IT WAS REPORTED THAT ONE OF THE BASKET WIRES FELL OFF FROM THE TIP OF THE BASKET. A PHOTO OF THE DEVICE WITH A BROKEN (REMAINED ATTACHED) BASKET WIRE WAS PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304942 ↗
• MalfunctionSep 8, 2017Break; Break

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK MEMORY EIGHT WIRE BASKET. THE DEVICE WAS TO BE USED FOR REMOVAL OF BILE DUCT STONE(S). HOWEVER, THE BASKET DID NOT OPEN/CLOSE AS INTENDED DURING VERIFICATION OF THE BASKET FUNCTION PRIOR TO USE, SO THE PHYSICIAN CHECKED THE DEVICE, THEN CONFIRMED THE BASKET WIRE BROKE AT APPROXIMATELY 10 CM FROM THE OUTER SHEATH TIP. THE DEVICE WAS REPLACED WITH ANOTHER MB5-2X4-8 (LOT # UNKNOWN), AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851336 ↗