RAIN Sheath Transradial 506610P22GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032082174), received between Mar 14, 2022 and Jul 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, PER THE PHYSICIAN, THE COATING OF A 6F 10CM PW22 TRANSRADIAL RAIN SHEATH WAS COMING OFF ONTO HIS FINGERS. THE PHYSICIAN HAD NOTICED THAT THE COATING WAS STICKY WHEN HE WAS HANDLING THE SHEATH AT HIS DESK. THERE WERE NO REPORTS OF PATIENT INJURY. NO WATER HAD BEEN APPLIED TO THE SHEATH. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286881 ↗
• InjuryMar 14, 2022Difficult to Remove; Output Problem; Difficult to Remove

  AS REPORTED, WHEN USING A 6F RAIN SHEATH IN A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN OBSERVED THE PATIENT HAD SEVERE RADIAL SPASM DURING THE INTERVENTION WHEN THE GUIDE CATHETER WAS USED WHICH MADE THE PROCEDURE DIFFICULT. AFTER THE PROCEDURE, THE PHYSICIAN ASSISTANT WAS UNABLE TO WITHDRAW THE SHEATH DUE TO THE SPASM EVEN AFTER ADMINISTERING NITROGLYCERIN. THE PATIENT WAS THEN GIVEN SEDATION TO LESSEN DISCOMFORT WHEN THE SHEATH WAS PULLED OUT.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Vasoconstriction

  MAUDE report 13758651 ↗