FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc 100027Recalls & reported problems
G.I. Windows, Inc. · The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic access to implant the magnet (dipolar magnet B) and OTOLoc contained in the cartridge. This architecture allows the user to reload a new Cartridge onto the Handpiece for the deployment of additional Implants as required by the surgical procedure. The user attaches the cartridge onto the Handpiece, inserts it through a trocar for use. After the implants has been fully deployed, the user can remove the FlexFire Universal Delivery Tool from the trocar and either reload it with another Cartridge for additional magnet implant deployments or discard it at the end of the procedure. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860012315536), received between Jun 21, 2026 and Jun 21, 2026 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure to Anastomose1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT IS A 73 YEAR MALE WITH A HISTORY OF ANEMIA, STAGE IV CHRONIC KIDNEY DISEASE, DIVERTICULOSIS, HEART FAILURE, HYPERLIPIDEMIA, AND HYPERTENSION, WHO HAD A PERFORATED CECUM AND UNDERWENT A RIGHT COLECTOMY WITH ILEOCOLOSTOMY AND DIVERTING LOOP ILEOSTOMY IN (B)(6) 2025. 10 MONTHS LATER THE PATIENT WAS TAKEN FOR OPEN ILEOSTOMY TAKEDOWN ON (B)(6) 2026 WITH COMPLEX PARASTOMAL HERNIA REPAIR. DURING THE OPEN SURGICAL PROCEDURE, THE PATIENT PRESENTED WITH SEVERAL ISSUES INCLUDING EVIDENCE OF SCAR TISSUE, ADHESIONS AND A CURRENT PERISTOMAL HERNIA. THE SURGEONS MADE A CIRCULAR INCISION AROUND THE STOMA TO FREE IT FROM THE SKIN AND ABDOMINAL WALL THEN MOBILIZED THE BOWEL BY DETACHING FROM THE ABDOMEN AND PULLING IT OUT SLIGHTLY TO LOCATE TWO HEALTHY, CLEAR ENDS OF THE SMALL INTESTINE. THE SURGEON NOTED THAT THE DISTAL ILEUM WAS VERY SMALL (LESS THAN 12 MM) AND REQUIRED DILATION USING A HEGAR DILATOR STARTING AT 12 MM AND CONTINUED TO 18 MM IN ORDER TO FIT THE MAGNETS (25 MM DIAMETER) WITHIN EACH LUMEN. THE MAGNETS OPERATED AS EXPECTED, DESPITE LIMITED SPACE FOR THE MAGNET TO FORM IN EACH BOWEL SEGMENT. THE MAGNETS WERE COUPLED TOGETHER TO COMPLETE A FULL IMMEDIATE FLOW ANASTOMOSIS. AF
Patient problems: Failure to Anastomose
MAUDE report 25572433 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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