RingRecalls & reported problems across all models
Cook Incorporated · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Ring model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 8 models of Ring by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2014 and Apr 3, 2026 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Material Separation” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Ring recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 26, 2025Open, Classified
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Z-0994-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported Ring problems
Device problems
- Material Separation5
- Break3
- Difficult to Remove3
- Detachment of Device or Device Component2
- Device Contaminated During Manufacture or Shipping2
- Difficult to Advance2
- Unsealed Device Packaging2
- Deformation Due to Compressive Stress1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Device Embedded In Tissue or Plaque3
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Insufficient Information1
- No Code Available1
- No Information1
Ring models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ring G29769INTRODUCER, CATHETER1 recall7 reports
- Ring G06541INTRODUCER, CATHETER1 recall1 report
- Ring G03388NEEDLE, CATHETER5 reports
- Ring G06909CATHETER, NEPHROSTOMY2 reports
- Ring G11956CATHETER, NEPHROSTOMY2 reports
- Ring G06990CATHETER, NEPHROSTOMY1 report
- Ring G12371CATHETER, BILIARY, SURGICAL1 report
- Ring G28035CATHETER, BILIARY, SURGICAL1 report
Recent Ring adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Difficult to Remove
IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENING CANNULA WAS DIFFICULT TO REMOVE FROM THE ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE FOR AN UNKNOWN PATIENT. THE USER NOTED THAT THE PLASTIC STIFFENING CANNULA BECAME JAMMED INSIDE THE CATHETER AFTER POSITIONING, RESULTING IN THE INABILITY TO FORM THE PIGTAIL CURL IN THE PATIENT. THE DRAINAGE CATHETER AND FLEXIBLE STIFFENING CANNULA WERE THEN REMOVED FROM THE PATIENT AS A UNIT AND A NEW LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A PHOTO OF THE DEVICE PROVIDED BY THE CUSTOMER CONFIRMS THAT THE STIFFENING CANNULA WAS LODGED IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782266 ↗MalfunctionNov 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H11.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23468858 ↗MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER SEPARATED AT THE HUB DURING REMOVAL FROM THE PATIENT FOLLOWING ITS PLACEMENT FOR A DRAINAGE PROCEDURE, RESULTING IN A PROCEDURAL DELAY. HOWEVER, THE ENTIRE DEVICE WAS SUCCESSFULLY RETRIEVED WITHOUT CAUSING ANY HARM TO THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22371946 ↗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 ↗MalfunctionOct 16, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE INNER PACKAGING OF AN ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER WAS FOUND TO BE UNSEALED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464539 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20409676 ↗MalfunctionDec 4, 2023Break; Difficult to Advance; Break; Difficult to Advance
ADDITIONAL INFORMATION WAS PROVIDED ON 07DEC2023. THE DAMAGE TO THE BLACK CATHETER AND SHEATH OCCURRED AS A RESULT OF ATTEMPTING TO MANEUVER THE OBTURATOR. THE TERM "MANEUVER" WAS CLARIFIED TO MEAN "ADVANCING THE OBTURATOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18260573 ↗MalfunctionAug 7, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469645 ↗MalfunctionJun 23, 2023Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17191641 ↗MalfunctionMar 7, 2023Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16495601 ↗MalfunctionFeb 22, 2021Flaked; Improper or Incorrect Procedure or Method; Flaked; Improper or Incorrect Procedure or Method
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11362213 ↗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 ↗MalfunctionFeb 18, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 9720495 ↗MalfunctionNov 15, 2019Material Puncture/Hole; Material Separation; Material Puncture/Hole; Material Separation
IT WAS REPORTED A RING TRANSJUGULAR INTRAHEPATIC ACCESS SET WAS USED IN A FEMALE PATIENT FOR A ENDOLUMINAL GRAFT ABDOMINAL AORTIC ANEURYSM ENDOLEAK REPAIR PROCEDURE. THE OPERATOR NOTICED A HOLE ON THE TEFLON CATHETER "A COUPLE CENTIMETERS FROM THE TIP". THE TIP OF THE CATHETER HAD "A LITTLE PIECE SHEER-OFF" OUTSIDE OF THE PATIENT, AND THE PHYSICIAN "CLIPPED OFF THE PIECE". A NEW, SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9329928 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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