Kendall 3615CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521138858), received between Apr 10, 2020 and Apr 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryApr 10, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE CUSTOMER REPORTED THAT THE PATIENT WAS TO HAVE SPINE SURGERY. THE PATIENT HAD LATEX/NATURAL RUBBER PRECAUTIONS RELATED TO SPINAL BIFIDA. PRIOR TO BRINGING THE PATIENT INTO THE OPERATING ROOM, PRODUCTS THAT CONTAINED LATEX FOR PATIENT CARE WERE REPLACED WITH LATEX FREE OPTIONS. IMMEDIATELY AFTER APPLYING FOUR INCH POSITIONING TAPE TO THE PATIENT'S LEG FOR TRACTION, THE PATIENT'S VITAL SIGNS DESATURATED. ANESTHESIA WAS CALLED IMMEDIATELY TO THE OPERATING ROOM AND THE PATIENT WAS STABILIZED. THE SURGICAL PROCEDURE WAS CANCELLED. LATER IN THE DAY THE SURGEON AND STAFF LEARNED THAT THE FOUR INCH POSITIONING TAPE USED IS COMPOSED OF LATEX AND NATURAL RUBBER. HOWEVER, THE TAPE IS REMOVED FROM THE OUTER PACKAGING AND PLACED ON AN EXCHANGE CART AND THE LABEL NOR THE ROLL STATES LATEX, ONLY THE OUTER BOX FROM PURCHASING STATES LATEX.

  Patient problems: Reaction

  MAUDE report 9948721 ↗