Ring G29769Recalls & reported problems
Cook Incorporated · Ring Transjugular Intrahepatic Access Set · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002297692), received between Feb 18, 2020 and Nov 4, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
- Difficult to Advance2
- Break1
- Deformation Due to Compressive Stress1
- Failure to Advance1
- Flaked1
- Improper or Incorrect Procedure or Method1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.