GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
Received Jul 8, 2026
Report 1820334-2026-00724 · MDR key 25752307
Device
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
Narrative
Description of Event or Problem
AS REPORTED, DURING ATTEMPTED RETRIEVAL OF AN UNSPECIFIED GUNTHER TULIP FILTER, A GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET¿S ¿WIRE¿ STUCK AROUND THE NECK OF THE FILTER AND COULDN¿T BE REMOVED. REPORTEDLY, THE WIRE REMAINED IN THE BODY, AND THE PATIENT WAS REFERRED TO ANOTHER FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Additional Manufacturer Narrative
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. H3: IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.