Inzii Retrieval SystemRecalls & reported problems across all models
Applied Medical Resources Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 796
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of Inzii Retrieval System by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 796 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2016 and Sep 24, 2026 — classified as 4 injuries, 791 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (211 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Inzii Retrieval System problems
Device problems
- Detachment of Device or Device Component211
- Detachment Of Device Component120
- Premature Separation113
- Activation, Positioning or Separation Problem92
- Break90
- Material Rupture80
- Material Split, Cut or Torn54
- Material Fragmentation28
Patient problems
- No Clinical Signs, Symptoms or Conditions392
- No Consequences Or Impact To Patient339
- No Known Impact Or Consequence To Patient54
- Foreign Body In Patient5
- Insufficient Information5
- No Patient Involvement3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Extravasation1
Inzii Retrieval System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Inzii Retrieval System CD001Laparoscope, General & Plastic Surgery355 reports
- Inzii Retrieval System CD003Laparoscope, General & Plastic Surgery284 reports
- Inzii Retrieval System CD004Laparoscope, General & Plastic Surgery157 reports
Recent Inzii Retrieval System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892481 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858556 ↗MalfunctionSep 15, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780946 ↗MalfunctionSep 9, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702243 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507297 ↗MalfunctionAug 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50434501 ↗MalfunctionAug 11, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212973 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Procedure performed: Lap Adnexectomy Event Description: On 25 June, there was a problem with an Inzii bag from Applied. Ref CD003, batch 1573509. Problem: a black thread would not come loose after the plunger broke off. This is said to have happened on several occasions. They couldn't take the cord from the hook to release the inzii bag back in the abdomen. First they took adnex out of bag and then they pulled out the bag with deployment system and trocar through the incision. Afterwards they took a new CD003.Type of Intervention: They took a new CD003.Patient Status: Patient ok.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181587 ↗InjuryAug 7, 2026Material Split, Cut or Torn
Procedure Performed: Bilateral Oophorectomy.Event Description: Inzii Universal Bag was deployed into the abdomen to collect the specimen (right ovary). They placed the right ovary into the bag and closed it shut. When they went to pull the bag out with the specimen in it the ovary was no longer in the bag. They are saying that they believe the bag popped or had a hole in it and the right ovary slipped out. They removed the bag with the ovary and then began searching around and through the bowls to find the detached right ovary. They searched for a while and could not find it. They decided it was best to close instead of performing a laparotomy to remove the right ovary. Patient was getting this procedure because it was a risk reduction as she has had cancer twice in the past. GYN Onc is now saying they are doing surgery again to go look and remove the right ovary. Patient is undergoing an additional surgery to find and remove the specimen. Her GYN Onc said it is not safe as a cancer risk patient to have her ovary floating around in the abdomen. She said she is undergoing an additional surgery because the bag did not perform how it is supposed to. The issue has yet to be resolved. P
Patient problems: Insufficient Information
MAUDE report 50178709 ↗MalfunctionAug 7, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50176821 ↗MalfunctionAug 7, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168696 ↗MalfunctionJul 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063859 ↗MalfunctionJul 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50061219 ↗MalfunctionJul 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059901 ↗MalfunctionJun 26, 2026Material Split, Cut or Torn
PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: MODEL WAS CD003. TIMING WAS DURING TREATMENT. EVENT DATE WAS 03JUN2026. WAS MADE AWARE AT THE TIME OF THE EVENT. BAG BROKE, TORE AT THE SEAM. NO PATIENT INJURY. NO OTHER DEVICES USED. REMOVED SPECIMEN MANUALLY WITH THEIR HANDS AND A CLAMP. NO, PRODUCT WAS THROWN AWAY BEFORE IT COULD BE RETRIEVED. ADDITIONAL INFORMATION PROVIDED BY [NAME] ON 05JUN2026 VIA EMAIL: PACKAGING WAS DISCARDED BEFORE IT COULD BE RETRIEVED FOR DOCUMENTATION. YES, SPECIMEN WAS COMPLETELY EXPOSED ONCE THE BAG BROKE. YES, THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. YES, THEY DID NOT EXTEND THE INCISION. THEY USED CLAMPS TO STRETCH THE FASCIA AND USED CIRCULAR MOTIONS WHEN TRYING TO PULL THE BAG OUT OF THE ABDOMEN. INTERVENTION: REMOVED SPECIMEN MANUALLY WITH THEIR HANDS AND A CLAMP PATIENT STATUS: NO PATIENT INJURY INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644188 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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