Inzii Ripstop Redeployable Retrieval System CD005Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00607915145521), received between Dec 6, 2024 and Aug 28, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507405 ↗
• MalfunctionJun 5, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: WE RECEIVED A CALL FROM A CUSTOMER AT [NAME]. SHE ADVISED WHEN SURGEON WAS USING PRODUCT ITEM CD005 WHEN DEPLOYED A PIECE FELL INTO THE PATIENT'S ABDOMEN. INFORMATION PROVIDED BY [NAME] VIA EMAIL THREAD ON (B)(6) 2026: DEPLOYING BAG, A PIECE FELL OFF INSIDE ABDOMEN., WHICH HAD TO BE RETRIEVED. INFORMATION PROVIDED BY [NAME] VIA EMAIL THREAD ON (B)(6) 2026: I HAVE A COMPLAINT BELOW ABOUT ANOTHER WHITE PIECE OF THE RIPSTOP 10MM BAG COMING OFF INTO THE PATIENT. THIS IS THE 2ND TIME THIS HAS HAPPENED IN 2 MONTHS FOR [NAME]. I WILL BE GOING THERE TOMORROW TO HELP FACILITATE THE RETURN AND SEE IF THERE MAY BE A DEPLOYMENT ISSUE ON THEIR END. THE CUSTOMER MENTIONED THEY SPOKE WITH CUSTOMER SERVICE YESTERDAY AND GAVE ALL PERTINENT INFORMATION. INFORMATION PROVIDED BY [NAME] VIA EMAIL ON (B)(6) 2026: THERE WAS NO SPILLAGE OUT OF THE BAG. THE BAG DID NOT BREAK INTO PIECES AND DID NOT COMPLETELY FALL OFF OF THE METAL SUPPORTS. NO, THE SUPPORTS DID NOT REMAIN INSIDE THE INTRODUCER TUBE. THE WHITE PLASTIC PIECE IN SHAFT CAME OUT AND INTO THE PATIENT WHEN DOING FINAL DEPLOYMENT. NO, THE ACTUATOR WAS NOT PUSHED FORWARD, RETRACTED, AND THEN DEPLOY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414046 ↗
• MalfunctionMay 15, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: I NEED TO START THE PROCESS OF A CER AS A PLASTIC PIECE OF A RETRIEVAL BAG SEEMINGLY BROKE OFF IN THE OR LAST MONTH. I WILL GIVE AS MUCH DETAILS AS I CAN, PLEASE LET ME KNOW WHAT ELSE YOU MAY NEED. THANK YOU! TIP OF BAG BROKE OFF IN PATIENT DURING PROCEDURE; SMALL PIECE WAS RECOVERED. WHAT IS THE LOT NUMBER OF THE CD005: 1571036. WERE THERE ANY OTHER INSTRUMENTS BEING USED AT THE TIME OF THE EVENT: RETRACTOR. WAS THERE ANY PATIENT INJURY? NO. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 17APR2026 VIA EMAIL: NO SPILLAGE. NO, GUIDE BEAD CAME OFF DUE TO EXCESSIVE FORCE DURING REMOVAL AND PLASTIC PIECE FELL INTO PATIENT. IT WAS RETRIEVED WITH NO ISSUE. BREAK OCCURRED AT GUIDE BEAD. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 20APR2026 VIA EMAIL: MY APOLOGIES, AFTER FURTHER CONVERSATION WITH THE CUSTOMER IT APPEARS IT WAS THE WHITE PLASTIC PIECE INSIDE THE TIP OF THE SHAFT. IT FELL OUT DURING DEPLOYMENT INTO THE PATIENT AND IT WAS RECOVERED. THE BAG DID WAS NOT COMPROMISED AND THERE WAS NO SPILLAGE. INTERVENTION: SMALL PIECE WAS RECOVERED. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25189835 ↗
• MalfunctionMay 1, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: NI EVENT DESCRIPTION: SURGEON SOMEWHAT NEW TO USING MODEL CD005 AND DURING SURGERY BECAME CONCERNED THAT SHE DID NOT SEE A GUIDE BEAD. THEREFORE, SHE DECIDED TO USE A NEW BAG, WHICH DID HAVE A VISIBLE BEAD. DUE TO THIS, THEY DID AN X-RAY ON THE PATIENT AND DID NOT SEE ANY PARTICULATE INSIDE THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 05FEB2026 VIA EMAIL: AFTER CONSULTING WITH THE SURGEON, WE DETERMINED THAT THE DEPLOYMENT BUTTON WAS NOT PUSHED AT THE CORRECT TIME. THE SURGEON WAS ATTEMPTING TO DEPLOY THE BAG AND EXPECTED TO SEE THE GUIDE BEAD BUT WAS UNABLE TO VISUALIZE IT. THE GUIDE BEAD WAS NOT VISIBLE BECAUSE THE DEPLOYMENT BUTTON WAS NOT ACTIVATED AT THE APPROPRIATE TIME, WHICH WOULD HAVE TRIGGERED THE BAG¿S FINAL DEPLOYMENT AND EXPOSED THE GUIDE BEAD. YES, THIS OCCURRED BEFORE THE ACTIVATION OF THE DELTA BUTTON. BASED ON DISCUSSION WITH THE TEAM, IT APPEARS THERE WAS CONFUSION ABOUT WHEN THE ACTIVATION BUTTON SHOULD BE PUSHED. NOTE: THIS WAS THE EMAIL FROM THE CUSTOMER; LAST WEEK, DR. [NAME] HAD A CASE WHERE SHE WAS USING ONE OF THESE BAGS, LOT # 1536457. DURING THE CASE, DR. [NAME] DID NOT SEE A BEAD AT THE TOP OF THE BAG TO CINCH THE BAG. S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059641 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC CHOLECYSTECTOMY EVENT DESCRIPTION: THE DEVICE WAS BEING USED TO REMOVE SPECIMEN. DURING THE PROCEDURE, THEY WERE HAVING DIFFICULTY WITH THE BAG-THEY WERE ABLE TO DEPLOY IT, BUT THEN IT WAS RESISTING CINCHING IT BACK UP. THE HANDLE/BAG FELL APART WHILE THEY WERE USING IT, AND THEY HAD TO SEARCH FOR AND RETRIEVE THE SMALL WHITE ROUND PIECE. THERE WAS NO CLINICAL IMPACT TO THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] BUT EMAILED BY [NAME] ON 13APR2026: NOT SURE, BUT WE BELIEVE NO THE ACTUATOR WAS NOT ABLE TO BE FULLY RETRACTED. BAG WAS NOT ABLE TO FULLY CINCH DUE TO SIZE OF GALLBLADDER YES-GALLBLADDER WAS A LITTLE TOO BIG FOR THE SIZE OF THE BAG. THE SPECIMEN WAS GALLBLADDER. YES, THE DELTA BUTTON WAS PRESSED BEFORE THE CUSTOMER EXPERIENCED ¿RESISTING CINCHING IT BACK UP." NO, BAG WOULD NOT RELEASE TO BE PULLED BACK UP INTO THE TUBE. NO, THE SPECIMEN WAS NOT COMPLETELY PULLED INTO THE TUBE. YES, THE DELTA BUTTON WAS PRESSED AND THE ACTUATOR WAS FULLY ADVANCED TO FULLY DEPLOY THE TISSUE BAG BEFORE THE CUSTOMER EXPERIENCED ¿RESISTING CINCHING IT BACK UP." THE ¿SMALL WHITE ROUND PIECE¿ WAS INSIDE THE PERITONEAL CAVITY OF THE PATIENT. THE SURGEON USE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958031 ↗
• MalfunctionMar 6, 2026Material Split, Cut or Torn

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: WHILE RETRIEVING THE SURGEON REALIZED IT WAS SPLITTING AT THE SEAM. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532520 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC APPENDECTOMY. EVENT DESCRIPTION: THE SURGEON STATED THAT SHE PUSHED THE PLUNGER FORWARD TO DEPLOY THE BAG, SHE PRESSED THE BUTTON, AND EXCELLED THE PLUNGER FORWARD (CORRECT STEPS), HOWEVER, WHEN SHE PULLED BACK THE PLUNGER THERE WAS NO BLACK STRING. SURGEON PUSHED THE PLUNGER FORWARD TO OPEN THE BAG BACK UP, AND SHE STATED THAT THE PLUNGER FELT CAUGHT OR STUCK. SHE PULLED BACK ON THE PLUNGER AGAIN. THE WHITE PIECE AND BLUE PIECE (IN PICTURE) BROKE OFF THE SHAFT INSIDE THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 21JAN2026: YES. THE WHITE PLASTIC PIECE AS WELL AS BLUE PLASTIC FROM THE SHAFT (IN PICTURE) WERE BROKEN INSIDE THE PATIENT. BOTH PARTS WERE FOUND AND REMOVED FROM THE PATIENT. IMAGES OF THE PACKAGING AS WELL AS THE BROKEN DEVICE ARE INCLUDED. INTERVENTION: PIECES WERE IDENTIFIED AND REMOVED FROM THE PATIENT'S ABDOMEN. PATIENT STATUS: RECOVERING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396059 ↗
• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: ROBOTIC LAP CHOLE. EVENT DESCRIPTION: UPON DEPLOYMENT, THE BAG WAS USED CORRECTLY, BUT WHEN THE SCRUB TECH PRESSED DOWN ON THE FINAL DEPLOYMENT BUTTON AND WENT TO PULL BACK AND CLOSE IT, IT WOULD NOT CLOSE AND THE WHITE PART OF THE INSIDE OF THE BAG WAS LOOSE. THEY PUSHED THE BAG BACK IN AND THEN USED AN ANCHOR BAG. WHEN THE BAG WAS LATER PULLED OUT TO CHECK WHAT HAD OCCURRED, THE WHITE PIECE FELL ONTO THE OPERATING ROOM FLOOR. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 31OCT2025 VIA EMAIL: THE CORRECT MODEL NUMBER IS CD005. NO PIECE OF THE INSTRUMENT FELL INTO THE PATIENT. THE WHITE PIECE OF DEPLOYMENT SYSTEM FELL OFF OUTSIDE OF THE PATIENT. INTERVENTION: REPLACED WITH AN [COMPETITOR] BAG. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652460 ↗
• MalfunctionNov 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY WITH LYMPH NODES. EVENT DESCRIPTION: THE BAG WAS BEING USED IN REDEPLOYABLE MODE TO BAG AND REMOVE INDIVIDUAL LYMPH NODES AND PULL BAG WITH SPECIMEN DIRECTLY THROUGH THE 1MM TROCAR CTF33 WHILE TROCAR REMAINED IN THE PATIENT. AFTER SEVERAL SUCCESSFUL SPECIMEN REMOVALS DURING THE CASE, THE LAST SPECIMEN WASN'T FITTING THROUGH THE TROCAR. HOWEVER, THE ATTEMPT TO PULL THE BAG THROUGH THE TROCAR RESULTED IN A COMPROMISED BAG. THE TROCAR AND BAG WERE REMOVED. TROCAR WAS REINTRODUCED. NO NEGATIVE CLINICAL PATIENT IMPACT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 30OCT2025: IT IS JUST THE ONE CD005 UNIT THAT MALFUNCTIONED. THE ACTUAL BAG WAS ACCIDENTLY THROWN AWAY BY THE HOSPITAL IN THE CLEANING PROCESS AND ONLY THE BAG DELIVERY SYSTEM WAS CLEANED/DECONTAMINATED. IT WAS THE BAG THAT WAS DAMAGED, NOT THE DELIVERY SYSTEM. THERE WASN¿T ANY SPECIMEN SPILLAGE AS THE BAG TORE BUT NOT WHERE THE SPECIMEN WAS LOCATED. THE BAG REMAINED IN ONE PIECE BUT TORE OR GAVE WAY IN THE CENTER OF THE BAG UNDER THE PRESSURE OF ATTEMPTING TO REMOVE THE BAG WITH SPECIMEN DIRECTLY THROUGH THE TROCAR, NOT THE INCISION. IT WOULDN¿T FIT INTO THE TROCAR. AT THAT POINT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622465 ↗
• MalfunctionJul 11, 2025Break; Break

  PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: NO SPECIFIC INFORMATION OTHER THAN "BAG BROKE" WAS PROVIDED. PLEASE NOTE WE DO NOT HAVE INFORMATION ON WHETHER PATIENT INJURY OCCURRED AND THE STATUS OF THE PATIENT. INTERVENTION: NI. PATIENT STATUS: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487153 ↗
• MalfunctionJul 10, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: ROBOTIC HYSTERECTOMY. EVENT DESCRIPTION: SPECIMEN RETRIEVAL BAG RIPPED WHEN TRYING TO REMOVE FROM PATIENT. THE PROCEDURE WAS COMPLETED. PATIENT CARE WAS NOT COMPROMISED. INTERVENTION: NI. PATIENT STATUS: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475813 ↗
• MalfunctionJul 10, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP. CHOLE WITH GRAMS. EVENT DESCRIPTION: BAG TORE AT BOTTOM AS SOON AS IT WAS CINCHED SHUT, AND HAD SLIGHT PRESSURE ON IT. INTERVENTION: NI. PATIENT STATUS: NI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22474705 ↗
• MalfunctionJun 13, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  PROCEDURE PERFORMED: LAP CHOLE. EVENT DESCRIPTION: I WAS AT [HOSPITAL] TODAY WORKING WITH DR [NAME]. HE HAD A LAP CHOLE AND WE HAD A CD005 BAG BREAK. THE PACKAGING WAS ALREADY THROWN AWAY SO I WAS UNABLE TO GET THE LOT NUMBER. THE SPECIMEN WAS BAGGED AND ALMOST OUT OF THE PATIENT THEN RIPPED AT THE BOTTOM SEAM. THE BAG WAS DEPLOYED CORRECTLY. THE BAG WAS GOING TO BE REUSED FOR THE GALLBLADDER. HE WAS REMOVING THIS STONE FIRST. HE PULLED BACK ON THE INTRODUCER AND THEN PULLED THE WHOLE THING AND TROCAR OUT. HE THEN TRIED TO WORK THE BAG THROUGH THE INCISION BUT HAD IT BREAK. A CD001 WAS OPENED TO FINISH REMOVING THE SPECIMEN AND NO ISSUES. THERE WAS NO PATIENT HARM. THE SPECIMEN WAS A LARGE STONE THE SIZE OF A GOLF BALL HARD AS A ROCK. WHEN THE OTHER BAG WAS USED THE SURGEON DID EXTEND THE INCISION. I HAVE THE BAG ITSELF REMOVED FROM THE INTRODUCER. ADDITIONAL INFORMATION OBTAINED FROM ACCOUNT MANAGER ON 21MAY2025: I ATTACHED A PICTURE OF THE SPECIMEN PREVIOUSLY. THERE WAS NO SPILLAGE AS IT WAS A LARGE STIFF MASS. THE BAG DID NOT BREAK INTO PIECES, ONLY AT THE SEAM. THE BAG DID NOT BURSE DURING SPECIMEN REMOVAL THROUGH THE TROCAR. THE TROCARS PULLED OUT AND THE BAG TOP WAS FOLLOWED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22207356 ↗
• MalfunctionJun 13, 2025Break; Break

  PROCEDURE PERFORMED: ROBOTIC PROSTATECTOMY. EVENT DESCRIPTION: COMPLAINT RECEIVED FROM CUSTOMER RELATIONS TEAM MEMBER: I RECEIVED A CALL FROM THE BELOW CONTACT REGARDING CD005 FAILURE. THE BAG BROKE IMMEDIATELY WITH SLIGHT PRESSURE AS SOON AS THEY BEGAN PULLING SPECIMEN. THE BAG WAS NOT FULL. ADDITIONAL INFORMATION OBTAINED FROM HOSPITAL REPRESENTATIVE VIA EMAIL ON 15MAY2025: NARRATIVE FROM ROOM STAFF: "BAG BROKE AS SOON AS STARTED PULLING SPECIMEN OUT. BAG WASN'T FULL, BUT BROKE IMMEDIATELY WITH SLIGHT PRESSURE. THE HOSPITAL IS UNABLE TO PROVIDE ANSWERS TO QUESTIONS ABOUT THE EVENT AND MALFUNCTION. INTERVENTION: UNK. PATIENT STATUS: NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204484 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  PROCEDURE PERFORMED: GALLBLADDER REMOVAL. EVENT DESCRIPTION: THE SURGEON PUT THE GALLBLADDER INSIDE THE SPECIMEN BAG AND IT THE SPECIMEN FELL COMPLETELY THROUGH; THE SEAM WAS NOT SEALED SHUT. THE BAG DID NOT BREAK INTO PIECES. THE SPECIMEN WAS SUCCESSFULLY REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 24MAR2025 VIA EMAIL: FROM MY UNDERSTANDING THE SPECIMEN WAS BAGGED, THE DEPLOYMENT SYSTEM WAS REMOVED AND AS THE SURGEON WENT TO LIFT THE GALLBLADDER OUT, IT JUST FELL OUT OF THE BAG THROUGH WHERE THE SEAM WOULD BE. IT DID NOT "BURST" OR "POP" OR "RIP" THE SEAM WAS NOT CLOSED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 13MAY2025 VIA EMAIL: THIS IS ALL SHE HAD, UNFORTUNATELY THERE¿S NOT MUCH TO TELL FROM THIS PICTURE, SORRY ABOUT THAT! INTERVENTION: USER REPLACE WITH A NEW ONE TO COMPLETE THIS SURGERY. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868799 ↗
• MalfunctionApr 18, 2025Break; Break

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THE BAG ON THE STRING BROKE WHILE THEY WERE PULLING IT OUT OF THE PATIENT. THE BAG WAS NOT FULL. THE BAG POPPED WHEN THEY WERE TAKING THE GALLBLADDER OUT OF THE PATIENT. [NAME] CONFIRMED THAT THERE WAS ONLY 1 MEDICAL DEVICE MALFUNCTION. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 24MAR2025. THE BOTTOM OF THE BAG BROKE AT THE SEAL AND THE SPECIMEN WAS LEFT IN THE ABDOMINAL WOUND. IT WAS A 12MM PORT. WE WERE ABLE TO GET IT OUT. THE GALLBLADDER HAD LARGE STONES. DR. [NAME] WAS PULLING FOREFULLY BUT NOT SO HARD THAT HE EXPECTED THE BAG TO BREAK. INTERVENTION: WE WERE ABLE TO GET IT OUT. PATIENT STATUS: THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867451 ↗
• MalfunctionDec 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: THERE WAS A WHITE PIECE OF PLASTIC THAT FELL OFF INSIDE THE TROCAR AFTER THE BAG WAS DEPLOYED. THE TEAM NOTICED IT RIGHT AWAY AND WAS ABLE REMOVED IT. THE PHYSICIAN SAID, "I THINK THE PIECE WAS SUPPOSED TO STAY AT DISTAL END BUT THIS ONE DID NOT. THIS IS A POTENTIAL SAFETY ISSUE IF IT¿S NOT RECOGNIZED BEFORE WOUND CLOSURE." ADDITIONAL INFORMATION OBTAINED FROM [NAME] VIA PHONE CALL ON (B)(6) 2024: NO INTERVENTION TAKEN. THE WHITE RETENTION COLLAR WAS STUCK IN A TROCAR. ONCE THEY REINTRODUCED A CAMERA TO LOOK, THE PHYSICIAN NOTICED A PIECE OF CD005 IN THE TROCAR. IT WAS REMOVED FROM THE TROCAR AND NOTHING FELL INTO THE PATIENT. ALL COMPONENTS WERE RETRIEVED. NO PATIENT INJURY OCCURRED. THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. THE BAG FUNCTIONED AS NORMAL. INTERVENTION: IT WAS REMOVED FROM THE TROCAR AND NOTHING FELL INTO THE PATIENT. PATIENT STATUS: NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20861052 ↗