Aprima G52964Recalls & reported problems
Cook Incorporated · Aprima Access Set Nonvascular Introducer Set Featuring Transitionless Technology · Class 1
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 00827002529649), received between Mar 19, 2015 and Mar 19, 2015 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2015Material Separation
WHEN ATTEMPTING TO PLACE A KIDNEY DRAINAGE CATHETER ON (B)(6) 2015, THE PHYSICIAN INSERTED THE ACCESS NEEDLE, THEN INSERTED THE COPE MANDRIL WIRE FROM AP RIMA SET. AFTER REMOVING THE NEEDLE AND MANIPULATING THE WIRE TO TRY TO GET PAST THE STRICTURE, THE PHYSICIAN REMOVED THE WIRE AND THE TECH NOTICED THAT THE FLOPPY TIP WAS NO LONGER PRESENT AFTER TAKING FURTHER IMAGES, THE TIP OF THE WIRE CAN BE SEEN INSIDE THE PATIENT'S KIDNEY THE PHYSICIAN STILL TRIED TO GAIN ACCESS TO PLACE THE DRAINAGE BY OPENING UP 3 SUBSEQUENT A PRIMA SETS, BUT WAS UNSUCCESSFUL IN GETTING PAST THE STRICTURE. IT WAS THEN DECIDED TO WAIT AND LET PATIENT HEAL UP FROM TODAY'S PROCEDURE BEFORE DECIDING THE NEXT COURSE TRY AGAIN TO PLACE DRAIN PERCUTANEOUSLY OR GO TO PARTIAL NEPHRECTOMY AS WAS PREVIOUSLY DISCUSSED AS A POTENTIAL COURSE OF TREATMENT FOR THE PATIENT. THERE WAS NOT AN ATTEMPT TO REMOVE THE TIP OF THE WIRE ON THIS DAY, BUT IF THEY DECIDE TO ATTEMPT PERCUTANEOUS ACCESS- THEY WILL TRY TO USE FORCEPS/SNARE TO REMOVE WIRE TIP. TECH STATED THAT THE PHYSICIAN DID NOT MOVE THE WIRE IN AND OUT OF THE NEEDLE DURING THE MANIPULATION. FOLLOW UP PROCEDURE: AFTER A SECOND ATTEMPT ON (B)(6) 2015 TO ACCESS THE KIDNE
Patient problems: Foreign Body In Patient
MAUDE report 4626996 ↗
Other ACCESSORIES, CATHETER devices
- Cook G00219Cook Incorporated · ACCESSORIES, CATHETER103 reports
- Discofix® 456020B. Braun Medical Inc. · ACCESSORIES, CATHETER60 reports
- IV Administration Set 490062B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Extension Set 456025B. Braun Medical Inc. · ACCESSORIES, CATHETER1 recall0 reports
- Centeze Centesis Catheter DRC-002-05Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Centeze Centesis Catheter DRC-002-06Galt Medical Corp. · Accessories, Catheter1 recall0 reports
- Neff G10544Cook Incorporated · ACCESSORIES, CATHETER45 reports
- Cook G06299Cook Incorporated · ACCESSORIES, CATHETER18 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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