Mini StingRay 8463540 0810Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10851978007402), received between Jun 19, 2026 and Jun 19, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Material Separation; Gas/Air Leak

  CUSTOMER MEDCO - REPORTED QUALITY ISSUES WITH THE WOUNDPRO MINI STINGRAY. (P/N 0810, LOT 1608); THE STINGRAY POLYMER CONNECTOR HAD VISIBLE "CRACKING". AFTER ONE PRODUCT IN USE EXHIBITED A LEAK, THE PRODUCTS (10 UNITS EACH PER CASE, 40 UNITS TOTAL) WERE EAXMANINED OUTSIDE CLINICAL USE TO ASSESS OTHERS WHICH MAY HAVE ANY VISBLE DEFECTS. APPROXIMATELY 10 OF THE 40 UNITS WERE SUSPECT OF POTENTIAL ISSUE AND WERE DISCARDED AND REPLACED BY PENSAR. THE LEAK OF THE CLINICAL USE COMPONENT DID NOT PREVENT OR THEREPY, BUT A DRESSING CHANGE WAS COMPLETED TO ELIMINATE ANY POTENTIAL ISSUE. DEVICES WERE NOT RETURNED. NO PATIENT HARM OR EVENT WAS REPORTED. CONSERVATIVE DETERMINATION: MDR REPORTABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566652 ↗