RAIN Sheath Transradial 506510SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032078917), received between Jan 22, 2020 and Jul 27, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Break; Difficult to Remove; Mechanical Jam; Difficult to Remove

  AS REPORTED, THE LAST PIECE OF THE THE 5F 10CM RAIN SHEATH WAS NOTED TO BE STUCK IN THE VESSEL WHEN REMOVING. AFTER REMOVAL FROM THE PATIENT, IT WAS NOTED THAT THE LAST 0.5CM OF THE TIP WAS DAMAGED. IT WAS CONFIRMED THAT THERE WAS NO DAMAGE TO THE SHEATH PRIOR TO INFLATING THE TR BAND. THERE WAS NO DIFFICULTY USING THE SHEATH DURING THE PROCEDURE, PRIOR TO INFLATING THE TR BAND. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS OCCURRED AT THE END OF THE PROCEDURE, AFTER THE TR-BAND WAS INFLATED AND THE SHEATH WAS BEING REMOVED. THE TR-BAND WAS DEFLATED; HOWEVER IT DID NOT RECOVER ITS ORIGINAL SHAPE. THE SHEATH WAS REMOVED WITH A QUICK MOVEMENT, AND THE TR -BAND WAS INFLATED AGAIN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109234 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 10CM SW TRANSRADIAL RAIN SHEATH WAS ADVANCED OVER THE STAINLESS-STEEL WIRE AND UPON INSERTION OF THE SHEATH, THE HYDROPHILIC COATING BEGAN TO SHEAR OFF. THE RAIN SHEATH WAS FULLY INSERTED, SIGNIFICANT AMOUNT OF HYDROPHILIC COATING WAS EVIDENT AT THE TISSUE TRACT INSERTION SITE. THERE WAS NO REPORTED PATIENT INJURY. THE RAIN SHEATH WAS PREPPED BY FLUSHING COMPONENTS AND DIPPING IN THE BOWL OF SALINE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937657 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HYDROPHILIC COATING OF A 5F 10CM TRANSRADIAL RAIN SHEATH INTRODUCER CAME OFF DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A HEART CATH. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE PRODUCT, OR ANY OF THE OTHER DEVICES USED WITH IT, HAD NOT BEEN RESTERILIZED. THERE WERE NO ANOMALIES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE ACCESS SITE WAS RADIAL. EXCESS FORCE WAS NOT USED DURING INSERTION. THE PATIENT HAS RECOVERED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883361 ↗
• MalfunctionFeb 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE FELLOW INSERTED THE WIRE OF A 5F 10CM SW RAIN SHEATH INTRODUCER INTO THE ENTRY NEEDLE AND THE WIRE FRAYED. THE DISTAL TIP OF THE WIRE BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DISLODGED TIP AND REMOVED THE ENTIRE WIRE AND TIP. TIP WAS DISLODGED IN THE SHEATH. SHEATH REMOVED AND FLUSHED TO RETRIEVE THE TIP. THERE WAS RESISTANT WITH THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD FOR FIVE DAYS. THE PRODUCT WAS NOT RESTERILIZED. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT RE-SHAPED BY THE USER. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329741 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE NEEDLE OF A 5F 10CM STAINLESS STEEL WIRE (SW) RAIN SHEATH INTRODUCER WAS FELT BLUNT. THE DEVICE WAS USED AS USUAL. THE PATIENT HAD LITTLE POST-INTERVENTIONAL BLEEDING AS THE ARTERY WAS PERFORATED. A PRESSURE BANDAGE WAS APPLIED AS A TREATMENT/PROCEDURE PROVIDED TO THE PATIENT AS A RESULT OF THE ARTERIAL PERFORATION. THE PRODUCT LOOK/APPEAR NORMAL WHEN TAKEN FROM ITS PACKAGING. THERE WAS NO ANY TREATMENT PROVIDED TO THE PATIENT AS A RESULT OF THE BLOOD LOSS. THE DEVICE WAS INTACT WHEN REMOVED FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE.

  Patient problems: Atrial Perforation

  MAUDE report 9616394 ↗