Lasso 1180-02Recalls & reported problems
Diversatek Healthcare, Inc. · Lasso Polypectomy Snare · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816734021576), received between Jan 6, 2023 and Jul 9, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO ADVERSE EVENT RELATED TO THIS INCIDENT. AS THE SNARE WAS CLOSING AROUND THE POLYP, THE SNARE WIRE BROKE OFF FROM THE CATHETER. THE WIRE PIECE WAS RETRIEVED AND NO PATIENT INJURY WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19705457 ↗InjuryJan 6, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
CUSTOMER REPORTED THIS ADVERSE EVENT TO IMPORTER ON DECEMBER 8, 2022. CUSTOMER REPORTED A PERFORATION DURING THE REMOVAL OF POLYPS FROM THE COLON. THE PROCEDURE BEING PERFORMED WAS A COLONSCOPY WITH A POLYPECTOMY X 2 (HEPATIC FLEXURE AND SIGMOID). THE ADVERSE EVENT REQUIRED A REPORTED SURGICAL INTERVENTION TO REPAIR THE PERFORATION. THE PATIENT HAD NO REPORTED UNDERLYING HEALTH ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT WAS HOSPITALIZED FOR 9 DAYS TOTAL.
Patient problems: Perforation
MAUDE report 16112410 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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