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Memory Basket G22002Recalls & reported problems

Cook Incorporated · Memory Hard Wire Basket · Class 2

Adverse event reports
17
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002220027), received between Oct 9, 2017 and May 14, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (9 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 2 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 3 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Fold, Unfold or Collapse9
  • Fracture5
  • Break3

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • No Consequences Or Impact To Patient2
  • No Patient Involvement2

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 14, 2026Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED TWO COOK MEMORY HARD WIRE BASKETS. IT WAS REPORTED THAT THE USER REMOVED THE STONE ONCE WITH THE DEVICE AND THEN COULD NOT RETRACT THE BASKET INTO SHEATH. 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 25177162 ↗
  • MalfunctionApr 27, 2026Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO REMOVE BILE DUCT STONES, THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE BASKET COULD NOT BE RETRACTED INTO THE SHEATH. DESPITE REPEATED ATTEMPTS TO PUSH AND PULL, THE SHEATH BECAME DEFORMED. SUBSEQUENTLY, THE BASKET WAS REMOVED AND A STONE RETRIEVAL BALLOON WAS USED TO EXTRACT THE STONES. 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 24999866 ↗
  • MalfunctionApr 24, 2026Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY HARD WIRE BASKET. IT WAS INITIALLY REPORTED THAT WHEN THE HANDLE WAS PULLED, THE SHEATH BUNCHED UP NEAR THE HANDLE, SO THE BASKET COULD NOT BE ADVANCED OUT OF THE SHEATH. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED AND WAS EVALUATED ON 31MAR2026. THE BASKET WOULD NOT FULLY RETRACT DUE TO KINKING IN THE TUBING AT THE BASE OF THE HANDLE [SUBJECT OF REPORT]. 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 24980078 ↗
  • MalfunctionApr 6, 2026Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE BASKET COULD NOT BE ADVANCED OR 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 24792404 ↗
  • MalfunctionJan 26, 2026Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED TWO COOK MEMORY HARD WIRE BASKETS. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THAT THE BASKET RETRACTION INTO SHEATH WAS DIFFICULT, AND WITH SLIGHTLY ADDITIONAL FORCE THE SHEATH KINKED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24177983 ↗
  • MalfunctionJan 19, 2026Fracture

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE DUODENOSCOPE REACHED THE DUODENAL PAPILLA AND SUCCESSFULLY INSERTED THE TUBE USING A COOK'S TRI SPHINCTEROTOME DEVICE. THE WIRE GUIDE REACHED THE RIGHT HEPATIC HILUM, AND THE IMAGING SHOWED THE SHAPE OF THE COMMON BILE DUCT. SMALL STONES WERE FOUND, AND THE WIRE GUIDE WAS RETAINED WITH THE EXCHANGE PRODUCT. THE STONE COLLECTION BASKET WAS OPENED, AND THE GAS WAS EXHAUSTED OUTSIDE THE BODY. IT WAS THEN TAKEN ALONG THE ENDOSCOPE WORKING CHANNEL TO REACH THE DUODENAL PAPILLA AND ENTERED THE BILE DUCT. AFTER PASSING OVER THE STONE, THE BASKET WAS OPENED, WRAPPED AROUND THE STONE, AND DRAGGED OUTSIDE THE DUODENAL PAPILLA. IT WAS FOUND THAT THE WIRE AT THE HEAD OF THE BASKET BROKEN, AND THE PRODUCT WAS REMOVED FROM THE BODY AND REPLACED. 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 24109113 ↗
  • MalfunctionDec 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED TWO COOK MEMORY HARD WIRE BASKETS. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THAT THE BASKET RETRACTION INTO SHEATH WAS DIFFICULT, AND WITH A LITTLE BIT OF ADDITIONAL FORCE THE SHEATH KINKED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23896743 ↗
  • MalfunctionDec 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED TWO COOK MEMORY HARD WIRE BASKETS. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THAT THE BASKET RETRACTION INTO SHEATH WAS DIFFICULT, AND WITH A LITTLE BIT OF ADDITIONAL FORCE THE SHEATH KINKED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23896692 ↗
  • MalfunctionNov 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN SELECTED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND DISCOVERED THAT THE [BASKET] RETRACTION INTO THE SHEATH WAS DIFFICULT. WITH SLIGHTLY ADDITIONAL FORCE, THE SHEATH KINKED. 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 23553857 ↗
  • MalfunctionJun 20, 2025Fracture; Fracture

    IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE USER OPENED THE BASKET PACKAGE AND FOUND OUT THE BASKET WIRE WAS BROKEN. THE USER CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22299606 ↗
  • MalfunctionApr 25, 2025Fracture; Fracture

    DURING STONE REMOVAL IN THE COMMON BILE DUCT, THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE USER SUCCESSFULLY COMPLETED THE CANNULATION AND INTO COMMON BILE DUCT, STONES WAS OBSERVED UNDER ANGIOGRAPHY, USER EXCHANGED THE WIRE GUIDE AND KEPT IT IN PLACE. THE USER THEN ADVANCED THE BASKET DEVICE INTO THE ENDOSCOPE WORKING CHANNEL AND SUCCESSFULLY INTO COMMON BILE DUCT, THEN PLACED THE BASKET ABOVE THE STONE, OPENED THE BASKET AND CAPTURED THE STONE SUCCESSFULLY. WHEN THE USER PULLED THE BASKET TOWARD THE DUODENUM AND RELEASED THE STONE, THEY OBSERVED THAT THE BASKET WIRE WAS BROKEN. THE USER RETRACTED THE DEVICE AND CHANGED TO ANOTHER DEVICE 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 21908005 ↗
  • MalfunctionApr 2, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

    DURING AN UNKNOWN PROCEDURE THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. A VIDEO WAS PROVIDED SHOWING THE USER EXPERIENCING DIFFICULTY AND INABILITY TO RETRACT THE BASKET. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21752897 ↗
  • MalfunctionMar 21, 2025Fracture; Fracture

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, ERCP, TO REMOVE STONES THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. IT WAS REPORTED THAT THE BASKET BROKE DURING THE STONE REMOVAL PROCESS AFTER ENTERING THE BILE DUCT. 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 21662996 ↗
  • MalfunctionDec 27, 2018Fracture; Fracture

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND [CAPTURED] A STONE. THEN THE USER PULLED THE DEVICE A LITTLE AND OBSERVED THAT A BASKET WIRE HAD BROKEN FROM THE DEVICE BODY [DURING] ENDOSCOPY. THE USER WITHDREW THE DEVICE FROM THE ENDOSCOPE IMMEDIATELY AND CONFIRMED THERE WAS NO DEVICE PART LEFT IN PATIENT. THE USER THEN USED ANOTHER OF THE SAME DEVICE AND FINISHED 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 Consequences Or Impact To Patient

    MAUDE report 8199682 ↗
  • MalfunctionMay 3, 2018Break; Break

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK MEMORY HARD WIRE BASKET. THE USER OPENED THE PACKAGE AND CHECKED THE INTEGRITY OF THE DEVICE AND FOUND OUT [THAT THE] BASKET WIRE [HAD] BROKEN.

    Patient problems: No Patient Involvement

    MAUDE report 7484627 ↗
  • MalfunctionApr 6, 2018Break; Break

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK MEMORY HARD WIRE BASKET. THE OPERATOR OPENED THE PACKAGE AND CHECKED THE INTEGRITY BEFORE USE. [IT WAS] FOUND THAT THE "WIRE GUIDE OF THE BASKET" WAS BROKEN. THE DEVICE WAS EVALUATED ON (B)(6) 2018. IT WAS DETERMINED THAT ONE OF THE WIRES ON THE BASKET HAD BROKEN LOOSE FROM THE PROXIMAL END OF THE BASKET AND WAS STILL ATTACHED AT THE DISTAL END OF THE BASKET.

    Patient problems: No Patient Involvement

    MAUDE report 7402272 ↗
  • MalfunctionOct 9, 2017Break; Break

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK MEMORY HARD WIRE BASKET. THE USER REMOVED THE STONE WITH THE DEVICE AND THE WIRE OF THE BASKET WAS BROKEN. THE USER REPLACED WITH A NEW DEVICE TO FINISH THE PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6932129 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.