Amplatz G11975Recalls & reported problems
Cook Incorporated · Amplatz Universal Drainage Catheter Ultrathane · Class U · Implant
All models of Amplatz (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002119758), received between Aug 4, 2022 and Aug 4, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent
IT WAS REPORTED A PATIENT REQUIRED REPLACEMENT OF AN ULTRATHANE AMPLATZ UNIVERSAL DRAINAGE CATHETER. ON (B)(6) 2022, THE DRAINAGE CATHETER WAS INITIALLY PLACED WITHOUT DIFFICULTY. THE PATIENT WAS DESCRIBED AS ACTIVE POSTOPERATIVELY. ONE WEEK AFTER PLACEMENT, ON (B)(6) 2022, A KINK AT THE PROXIMAL SIDE OF THE DRAINAGE CATHETER WAS FOUND. THE CATHETER WAS REPLACED WITH A NEW CATHETER SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15164121 ↗
Other CATHETER, NEPHROSTOMY devices
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- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Cook G09767Cook Incorporated · CATHETER, NEPHROSTOMY1 recall9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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