RAIN Sheath Transradial 506510NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032082150), received between May 30, 2023 and Jul 6, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 5F 10CM TRANS-RADIAL RAIN SHEATH KEPT KINKING ON THE END AND IN THE CENTER. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS OPENED IN A STERILE FIELD AND WAS USED IN PATIENT. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE CANNULA OF THE CATHETER SHEATH INTRODUCER (CSI) PRESENTS AN ACCORDIONED CONDITION LOCATED APPROXIMATELY ON 8 CM FROM THE DISTAL TIP. ALSO, THE CANNULA PRESENTS A FRAYED CONDITION ON THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19685995 ↗
• InjuryNov 15, 2023Fracture; Fracture

  AS REPORTED, THE NITINOL WIRE IN THE 5F 10CM RAIN SHEATH TRANSRADIAL KIT BECAME KNOTTED UPON ADVANCEMENT THROUGH THE NEEDLE. IN ATTEMPTING TO REMOVE THE WIRE, THE DISTAL ASPECT OF THE WIRE BROKE OFF AND REMAINED IN THE PATIENT. THE INTENDED PROCEDURE WAS REPORTED TO BE A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY. LESION CALCIFICATION WAS MODERATE WITH NO VESSEL TORTUOSITY OR STENOSIS BUT A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. RESISTANCE WAS EXPERIENCED ADVANCING THE WIRE. NO UNUSUAL FORCE WAS NECESSARY DURING USE OF THE DEVICE. THE SEPARATED SEGMENT WAS LEFT IN THE PATIENT, BUT THE WIRE IS EXTRA VASCULAR, AND THE PATIENT IS FOLLOWING UP WITH GENERAL SURGERY. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. A PROCEDURAL CD IS NOT AVAILABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144742 ↗
• MalfunctionAug 4, 2023Fracture; Fracture

  AS REPORTED, THE GUIDEWIRE OF A 5F 10CM RAIN TRANS-RADIAL CATHETER SHEATH INTRODUCER (CSI) WAS SPLIT INTO TWO PARTS DURING PREPARATION OF THE DEVICE. AS A RESULT, THE SAME 5F 10CM RAIN CSI WAS USED WITH AN UNKNOWN GUIDEWIRE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THERE WERE NO DIFFICULTIES DURING THE INSERTION OR WITHDRAWAL OF THE CSI. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17463278 ↗
• MalfunctionMay 30, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, A 5F 10 CM TRANS RADIAL RAIN SHEATH ACCORDIONED AS IT WAS ATTEMPTED TO BE INSERTED IN A LEFT PEDAL ARTERY WITH GUIDED ULTRASOUND (US). THERE WAS DIFFICULTY INSERTING AND WITHDRAWING DUE TO THE ACCORDIONED CONDITION OF DEVICE. WHEN ATTEMPTING TO REMOVE THE SHEATH OVER THE WIRE. THE CSI WIRE BECAME ENTRAPPED DURING THE PROCEDURE AND ABNORMAL FORCE WAS REQUIRED WHEN WITHDRAWING THE DEVICE. THE WIRE AND SHEATH WERE REMOVED. THE DISTAL TIP OF THE WIRE BROKE OFF THE REST OF THE WIRE. THE WIRE WAS SUCCESSFULLY RETRIEVED AND REMOVED BY THE PHYSICIAN. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS USED IN AN INTERVENTIONAL ENDOVASCULAR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE DEVICE WAS PREPPED, FLUSHED, AND WIPED WITH HEPARINIZED SALINE PRIOR TO INSERTION TO ACTIVATE THE HYDROPHILIC COATING. THE SHEATHS ARE STORED IN THE PRODUCT BOX IN A TEMP/HUMIDITY-CONTROLLED PROCEDURE ROOM. THE SHEATH WAS INSPECTED PRIOR TO USE, WITH NO DEFECTS NOTED. SEVERE CALCIFICATION WAS NOTED BY THE PHYSICIAN VIA ULTRASOUND. THE LENGTH OF STAY WAS NOT INCREASED DUE TO THE PRODUCT MALFUNCTION. ANOTHER 5F RAIN SHEATH WAS USED FOR THE PROCEDURE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026416 ↗