RAIN Sheath TransradialRecalls & reported problems across all models

We found 6 models of RAIN Sheath Transradial by Cordis US Corp. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2019 and Oct 17, 2025 — classified as 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RAIN Sheath Transradial problems

RAIN Sheath Transradial models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RAIN Sheath Transradial 506610S

  INTRODUCER, CATHETER
  25 reports
• RAIN Sheath Transradial 506510N

  INTRODUCER, CATHETER
  4 reports
• RAIN Sheath Transradial 506610H

  INTRODUCER, CATHETER
  2 reports
• RAIN Sheath Transradial 506610P22G

  INTRODUCER, CATHETER
  2 reports
• RAIN Sheath Transradial 506616S

  INTRODUCER, CATHETER
  1 report
• RAIN Sheath Transradial 506610N

  INTRODUCER, CATHETER
  1 report

Recent RAIN Sheath Transradial adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 6F 10 CM RAIN SHEATH TRANSRADIAL HYDROPHILIC THIN-WALLED INTRODUCER SHEATH UNRAVELED AND COULD NOT BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT EVENT DATE AND THE LOT NUMBER WERE NOT PROVIDED. ONE IMAGE WAS PROVIDED, AND IT SHOWS WHAT APPEARS TO BE THE DISTAL END OF THE CANNULA OF A CATHETER SHEATH INTRODUCER WITH A GRAY VESSEL DILATOR INSERTED THROUGH IT. THE DISTAL TIP OF THE CANNULA APPEARS DAMAGED; HOWEVER, IT CANNOT BE DETERMINED IF THE TIP IS FRAYED, SPLIT, TORN, OR ACCORDIONED. THE AFFECTED DEVICE HAS BLOODY RESIDUE ON IT, SUGGESTING AN ATTEMPT WAS MADE TO INSERT THE DEVICE INSIDE A PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324290 ↗
• MalfunctionAug 8, 2025Fracture; Stretched; Unraveled Material; Fracture; Stretched; Unraveled Material

  AS REPORTED, THE 6F 10CM TRANS-RADIAL RAIN SHEATH INTRODUCER WOULD NOT GO INTO RADIAL ARTERY. THE DEVICE BUNCHED UP. THE PROCEDURE WAS COMPLETED BY SWITCHING TO THE FEMORAL APPROACH. THERE WERE NO REPORTS OF PATIENT INJURY. THE INSERTION SITE WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE DEVICE WAS FLUSHED PRIOR TO USE, AND THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO PATIENT-SPECIFIC ANATOMICAL ANOMALIES NOTED AT THE INSERTION SITE. INSERTION DIFFICULTIES WERE EXPERIENCED AT THE PROXIMAL SECTION WHILE TRYING TO INSERT THE SHEATH. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR ITS PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE IFU. ALTHOUGH, THE CATHETER SHEATH INTRODUCER (CSI) WAS ONLY DIPPED AND NOT SOAKED OR WIPED DOWN WITH A WET GAUZE. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE MINI GUIDEWIRE IS INSERTED INTO THE NEEDLE PRESENTING AN UNRAVEL AND A FRACTURED/SEPARATED CONDITION ON THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754161 ↗
• MalfunctionNov 1, 2024

  WHEN REMOVING A DIAGNOSTIC CATHETER FROM THE RIGHT RADIAL ARTERY, THE CATHETER GOT STUCK AND WOULD NOT COME OUT OF THE SHEATH. ULTIMATELY THE ENTIRE SHEATH WAS REMOVED, AND OBVIOUS DAMAGE WAS APPRECIATED TO THE SHEATH. THIS WAS ALREADY THE PLANNED END OF THE PROCEDURE; NO APPARENT HARM WAS OBSERVED. A RADIAL BAND WAS PLACED TO RIGHT WRIST AS USUAL PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586726 ↗
• 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 ↗
• MalfunctionJan 11, 2024Partial Blockage; Partial Blockage

  AS REPORTED, THE DILATOR OF A 6F 10CM RAIN TRANS RADIAL CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE FLUSHED DUE TO AN OBSTRUCTION WITHIN THE DILATOR. AN IMAGE OF THE 6F RAIN CSI DILATOR WAS PROVIDED. IN THE IMAGE, AN UNKNOWN GUIDEWIRE CAN BE SEEN EXITING THE DISTAL TIP OF THE 6F RAIN CSI DILATOR. AN UNKNOWN SUBSTANCE CAN BE SEEN AT THE TIP OF THE GUIDEWIRE AS IT EXITED THE DISTAL TIP OF THE 6F RAIN CSI DILATOR. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NEVER USED INSIDE OF THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499102 ↗
• 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 ↗
• MalfunctionOct 27, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF THE DILATOR OF A 6F 10CM SF RAIN SHEATH TRANS-RADIAL THIN-WALLED SHEATH WAS CRUSHED, UPON OPENING. IT WAS PURGED AND THE SOLUTION CAME OUT FROM THE SIDE. THEREFORE, THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RAIN SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE PACKAGING OR SHIPPING BOX OF THE DEVICE. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. ADDENDUM: PRODUCT EVALUATION SHOWS A FRAYED CONDITION ON THE DISTAL TIP OF THE VESSEL DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023477 ↗
• MalfunctionSep 11, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A 6F 10CM RAIN SHEATH RADIAL CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE INTRODUCED INTO THE RADIAL ARTERY BUT "SCRATCHED" OFF. THE COATING OF THE SHEATH PULLED OFF AND PUSHED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER NON CORDIS CSI. THERE WAS NO REPORTED PATIENT INJURY. THE CSI WAS SOAKED; IT WAS NOT WIPED DOWN WITH WET GAUZE. THE PATIENT DID NOT HAVE ANY UNUSUALLY TOUGH SKIN, SCAR TISSUE, OR CONTRACTURES OF THE JOINT. THE PROCEDURE WAS COMPLETED USING ANOTHER NON CORDIS CSI. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719722 ↗
• InjuryAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F 10CM TRANSRADIAL RAIN SHEATH SEPARATED ABOUT 1CM FROM THE HUB INSIDE A VEIN WHEN THE PHYSICIAN WENT TO REMOVE THE SHEATH. A SURGEON WAS CALLED, AND THE PATIENT HAD A CUT-DOWN PROCEDURE TO REMOVE THE REMAINING CANNULA OF THE SHEATH. THE PROCEDURE WAS ABORTED DUE TO THE COMPLICATION. THE PATIENT IS DOING WELL AFTER THE PROCEDURE. A PHYSICIAN WENT TO GAIN RIGHT RADIAL ACCESS AND STUCK THE VEIN. THE PHYSICIAN THEN PROCEEDED AND PLACED A 6F RAIN TRANSRADIAL SHEATH INSIDE THE VEIN. THE PHYSICIAN THEN TRIED TO GAIN ACCESS TO THE RIGHT RADIAL ARTERY AND DID SUCCESSFULLY. A 6F RAIN SHEATH WAS PLACED INSIDE OF THE ARTERY. AN UNKNOWN J-WIRE WAS USED. GETTING ARTERIAL ACCESS POTENTIALLY NICKED THE VENOUS SHEATH IN PLACE AND THE INTEGRITY OF THE CANNULA "MAY HAVE BEEN DAMAGED CAUSING THE BREAK IN THE SHEATH UPON REMOVAL". THERE WERE NO DAMAGES NOTED TO THE DEVICE PRIOR TO USING IT. THERE WAS NO CALCIFICATION OR TORTUOSITY AT THE INSERTION VESSEL SITE. THERE WERE NO SPECIFIC PATIENT ANATOMICAL ANOMALIES NOTED AT THE INSERTION SITE. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN,

  Patient problems: Foreign Body In Patient

  MAUDE report 17592821 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 27, 2023Crack; Crack

  AS REPORTED, A 6F RAIN SHEATH TRANSRADIAL INTRODUCER WAS USED AND WHEN IT WAS PULLED, THE DISTAL END WAS CRACKED. THE DAMAGE WAS NOTICED UNTIL AFTER THE CASE WAS COMPLETED AND THE SHEATH WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING RIGHT RADIAL ACCESS (RRA). THE PHYSICIAN DID NOT NOTICE ANYTHING ¿ODD¿ UPON INSERTION. THE DEVICE WAS STORED AND OPENED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ISSUES REMOVING SHEATH FROM THE PACKAGING. THE DEVICE WAS NOT CRACKED PRIOR TO INSERTION. THERE WAS NO CALCIFICATION NOTED. VESSEL/LESION CHARACTERISTIC WERE REPORTED AS DOMINANT RIGHT CORONARY ARTERY (RCA); PROXIMAL PORTION THIRTY-PER CENT (30%) TUBULAR NARROWING WITH CALCIFICATION BIFURCATING IN PATENT DUCTUS ARTERIOSUS (PDA) AND LARGE POSTEROLATERAL SYSTEM WITH MODERATE DISEASE. VESSEL TORTUOSITY WAS NOT NOTED IN THE REPORT; DISTAL RCA WAS MODERATELY CALCIFIED WITH NINETY PER-CENT (90%) STENOSIS. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE CSI WAS SOAKED IN STERILE HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION DURING THE SAMPLE PREP STEP PER THE INSTRUCTIONS FOR USE (IFU)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207767 ↗
• 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 ↗
• MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 6F,10CM RAIN SHEATH DID NOT WANT TO INSERT ALL THE WAY WHILE ULTRASOUND GUIDED ACCESS TO THE RADIAL ARTERY WAS PERFORMED. WHEN THEY TRIED TO DRAW BACK BLOOD, AIR AND CLOT WERE OBSERVED IN THE SHEATH. THE DECISION WAS MADE TO ABORT THAT SITE AND TRY MORE DISTAL CLOSER TO THE WRIST. THE PHYSICIAN NOTED EVENLY SPACED ¿KINKS¿ IN SHEATH, AND THE PHYSICIAN ASKED FOR 6 F RAIN SHEATH WHICH WENT IN AND PERFORMED PERFECTLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO PATIENT SPECIFIC ANOMALIES NOTED AT THE INSERTION SITE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE CSI WAS SOAKED AND INSERTED HALF-WAY BEFORE EXPERIENCING INSERTION DIFFICULTIES. THE PATIENT HAD NOT RECEIVED ADEQUATE ANTICOAGULATION SINCE THE SHEATH WAS BEING INSERTED. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16961821 ↗
• MalfunctionApr 21, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, A 6F 10CM SW RAIN SHEATH TRANS-RADIAL SHEATH INTRODUCER ACCORDIONED AND GOT STUCK IN THE PATIENT'S ARM. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784913 ↗

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