MEDLINE MSC4224EPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10197344102778), received between May 11, 2026 and Jun 3, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT "REQUIRED ADDITIONAL PROCEDURE TO RESTART NEW EPIDURAL LINE" DUE TO "TAPE THAT FAILED TO ADHERE LINE TO SKIN." PER THE CUSTOMER, A "PAINFUL SECOND PROCEDURE [WAS] NEEDED TO ADEQUATELY CONTROL LABOR PAIN."

  Patient problems: Discomfort; Inadequate Pain Relief; Pain

  MAUDE report 25377257 ↗
• InjuryJun 3, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2026 "TAPE WAS USED TO ADHERE CATHETER TO PATIENT AFTER INSERTION OF AN EPIDURAL LINE. TAPE DID NOT HOLD LINE/CATHETER IN PLACE CAUSING LINE TO BECOME DISLODGED." PER THE CUSTOMER, THE "PATIENT REQUIRED ADDITIONAL PROCEDURE TO RESTART NEW EPIDURAL LINE" REQUIRED FOR "PAIN MANAGEMENT" OF LABOR. PER THE CUSTOMER, THE PATIENT EXPERIENCED AN "ADDITIONAL PAINFUL PROCEDURE."

  Patient problems: Discomfort; Inadequate Pain Relief; Pain

  MAUDE report 25376605 ↗
• MalfunctionMay 11, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT, ANESTHESIA DEPARTMENT IS REPORTING THAT THE TUBING IS FALLING OFF DUE TO THE LACK OF ADHESIVE ON THE TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25144644 ↗