Ring G03388Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002033887), received between Nov 13, 2014 and Jan 21, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREOPERATIVE PREPARATION, A NURSE IDENTIFIED THAT THE PACKAGING OF A RING DRAINAGE CATHETER NEEDLE SET WAS UNSEALED AT ONE END, COMPROMISING THE STERILITY OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200821 ↗
• MalfunctionDec 1, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED 15DEC2020: THE OPERATOR REPORTED THAT AFTER GOING THROUGH THE CUFF, THE NEEDLE/SHEATH WAS RETRACTED ABOUT 1 CM AS A UNIT TO REPOSITION THE TIP. SIGNIFICANT RESISTANCE WAS FELT DURING RETRACTION, SO THE OPERATOR REPORTED THE WHOLE SET WITH SLOW, STEADY TENSION. UPON REMOVAL, THE DISTAL PORTION OF THE SHEATH WAS EXAMINED AND IT WAS NOTED THAT IT HAD SHEARED OFF BUT THE DEVICE WAS RETRIEVED IN ITS ENTIRETY. PRELIMINARY EXAMINATION OF THE DEVICE RETURNED TO COOK ON 30 NOV 2020 SHOWED THE WHOLE CATHETER STILL ON THE NEEDLE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10926765 ↗
• MalfunctionNov 15, 2019Material Separation; Material Separation

  IT WAS REPORTED AN AFRICAN-AMERICAN PATIENT, UNKNOWN GENDER OR EXACT AGE, REQUIRED A RING DRAINAGE CATHETER NEEDLE SET DURING A TRANS-VAGINAL PROCEDURE TO DRAIN A VAGINAL ABSCESS AND HEMATOMA. THE OPERATOR ADVANCED THE ENTIRE DEVICE, THEN REMOVED THE STYLET AND PLACED WIRE THROUGH THE NEEDLE AND CATHETER AND PULLED 'YELLOW' CATHETER OFF. IT WAS DURING THIS MANEUVER THAT THE OPERATOR STATED HE "FELT TENSION" AND "THE HUB BROKE LOOSE AND COMPLETELY DETACHED." UPON REMOVAL OF THE CATHETER, THE OPERATOR THEN NOTICED APPROXIMATELY 1-2CM OF THE CATHETER TIP WAS MISSING. UNDER FLUOROSCOPY, THE OPERATOR CONFIRMED THE TIP WAS RETAINED INSIDE THE ABSCESS. THE OPERATOR MADE SEVERAL ATTEMPTS TO RETRIEVE THE CATHETER TIP FROM THE PATIENT. THE OPERATOR ATTEMPTED TO USE UNSPECIFIED COOK VASCULAR RETRIEVAL FORCEPS AND A SNARE DEVICE FROM ANOTHER MANUFACTURER. IT WAS REPORTED DUE TO ACUTE ANGLES WITHIN THE ANATOMY, THE OPERATOR WAS UNSUCCESSFUL AT RETRIEVING THE CATHETER TIP. THE LOCATION OF THE CATHETER TIP WAS MARKED WITH AN 8.5FR DAWSON- MUELLER DRAINAGE CATHETER. PATIENT WAS SUBSEQUENTLY TAKEN TO THE OPERATING SUITE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED BY ANOTHER OPERATOR AND CATHETER TIP W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9328362 ↗
• InjuryNov 15, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 9328333 ↗
• InjuryNov 13, 2014Material Fragmentation; Difficult to Remove; Material Separation

  A (B)(6) MALE PT UNDERWENT A CT GUIDED ABSCESS DRAINAGE/NEEDLE ASPIRATION. CT GUIDED NEEDLE ASPIRATION OF SMALL FLUID COLLECTION ANTERIOR UPPER ABDOMEN. ASPIRATION RESULTING IN ITS CLEARING. ON REMOVAL OF THE TUBE, THE PHYSICIAN NOTED THAT THE END OF THE RING DRAINAGE CATHETER NEEDLE APPEARED TO BE MISSING. THE SMALL CALIBER DRAINAGE TUBE FRAGMENTED UPON REMOVAL AND A 2CM LONG FRAGMENT WAS LEFT WITHIN THE PT. THE PHYSICIAN FEELS MATERIAL MAY NOT PROVE TO BE PROBLEMATIC AND A DECISION WAS MADE NOT TO REMOVE THE FRAGMENT. THE PT WILL BE OBSERVED FOR SIGNS AND SYMPTOMS OF INFECTION. UPON POST INSPECTION OF THE PRODUCT BY THE PHYSICIAN, THE CATHETER BROKE INTO TWO ADD¿L PIECES WITH MINIMAL MANIPULATION. THE PT WAS MADE AWARE OF THE INCIDENT. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; Nonresorbable materials, unretrieved in body

  MAUDE report 4352815 ↗