AMPLATZ GOOSE NECKRecalls & reported problems across all models
Ev3, Inc · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 10 models of AMPLATZ GOOSE NECK by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between May 17, 2021 and Sep 15, 2026 — classified as 10 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 reports).
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
Most reported AMPLATZ GOOSE NECK problems
Device problems
- Detachment of Device or Device Component18
- Material Deformation5
- Device Damaged by Another Device1
- Difficult to Remove1
- Entrapment of Device1
- Nonstandard Device1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Device Embedded In Tissue or Plaque2
- Insufficient Information2
- Unspecified Tissue Injury2
- Embolism/Embolus1
AMPLATZ GOOSE NECK models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AMPLATZ GOOSE NECK™ GN2000Catheter, embolectomy7 reports
- AMPLATZ GOOSE NECK™ GN2500Catheter, embolectomy6 reports
- AMPLATZ GOOSE NECK™ GN1500Catheter, embolectomy3 reports
- AMPLATZ GOOSE NECK™ GN1000Catheter, embolectomy1 report
- AMPLATZ GOOSE NECK™ GN3000Catheter, embolectomy1 report
- AMPLATZ GOOSE NECK™ SK200Catheter, percutaneous1 report
- AMPLATZ GOOSE NECK™ SK201Catheter, percutaneous1 report
- AMPLATZ GOOSE NECK™ SK400Catheter, percutaneous1 report
- AMPLATZ GOOSE NECK™ SK401Catheter, percutaneous1 report
- AMPLATZ GOOSE NECK™ SK700Catheter, percutaneous1 report
Recent AMPLATZ GOOSE NECK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Detachment of Device or Device Component; Material Deformation
It was reported a Micro Snare was used in attempt to retrieve the detached tip of the guidewire. One side of the snare loop came off, and it no longer functioned as a snare. A 6fr sheath and non Medtronic guidewire were used. The vascular condition was described as calcified. The joint on one side of the snare loop was damaged. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771538 ↗MalfunctionAug 25, 2026Nonstandard Device; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432431 ↗MalfunctionDec 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT HAD A SCHEDULED IVC FILTER RETRIEVAL ATTEMPT. A GOOSENECK SNARE WAS USED IN ACCORDANCE WITH THE IFU. POST-PROCEDURE, A NEWLY IDENTIFIED 1MM RADIOPAQUE BAND WAS NOTED IN THE CRANIAL ASPECT OF THE IVC. FOLLOWING THE CASE, THE GOOSENECK SNARE RETRIEVAL DEVICE WAS COMPARED WITH A NEW/UNUSED DEVICE, AND THE 1MM RADIOPAQUE BAND WAS NOTED TO BE ABSENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799511 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE GOOSENECK SNARE, THE RADIOPAQUE MARKER ON THE DISTAL END OF THE GOOSENECK SNARE DETACHED AND WAS LEFT IN THE VESSEL. THE DEVICE WAS SAFELY REMOVED, HOWEVER THE RADIOPAQUE MARKER IS ASSUMED TO BE FLOATING IN LEFT ATRIUM. THE PATIENT HAD NO HEALTH CONSEQUENCES OR IMPACT OR INTERVENTION DUE TO THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466639 ↗InjuryNov 18, 2024Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device
A PHYSICIAN WAS ATTEMPTING TO USE A NON-MEDTRONIC (ABBOTT) STENT TO TREAT A PATIENT. THE VESSEL WAS PRE AND POST DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WAS REPORTED, A SNARE WAS STUCK ON A STENT IN THE PATIENT, IT BROKE SO THE LOOP PORTION IS TACKED AGAINST THE VESSEL WALL WITH A VBX. TO REMOVE, PULLED WITH RESISTANCE, REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY/INTERVENTION. NO VESSEL DAMAGE REPORTED. PROCEDURE ABORTED, NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707225 ↗InjuryOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS PERFORMING A VENOUS EMBOLIZATION (PELVIC CONGESTION SYNDROME) IN THE OVARIAN VEIN AND REMOVED A MISPLACED COIL USING AN AMPLATZ GOOSENECK SNARE. INITIALLY, THE COIL WAS PARTIALLY IN THE OVARIAN VEIN, BUT IT COULDN'T BE REMOVED USING THE GOOSE NECK. AFTER REPOSITIONING IT WITH A BALLOON, IT WAS SUCCESSFULLY RETRIEVED WITH THE SNARE. UPON COIL REMOVAL, IT WAS DISCOVERED THAT THE MARKER HAD DETACHED FROM THE CATHETER BELONGING TO THE GOOSENECK SNARE AND HAD MIGRATED TO THE RENAL VEIN. NOTABLY, THE CATHETER WITH THE MARKER WAS FIRST ATTEMPTED TO BE INSERTED VIA A 7F GUIDING SHEATH, BUT THIS WAS UNSUCCESSFUL, LEADING TO ITS INTRODUCTION VIA A REGULAR SHEATH. THE PHYSICIAN TRIED TO RETRIEVE THE MARKER, BUT DID NOT SUCCEED. SO IT WAS LEFT IN THE RENAL VEIN WITHOUT COMPLICATIONS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20505630 ↗InjuryJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A GOOSENECK SNARE WITH A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS LEFT DISTAL TIBIAL/POPLITEAL TRUNK. MODERATE VESSEL CALCIFICATION WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE RADIOPAQUE MARKER ON THE SNARE CATHETER DISLODGED AND WAS JAILED WITH A CORONARY STENT. A SECOND SNARE WAS OPENED AND THE INTERGRAGED EMBOLIC PROTECTION WAS REMOVED BUT THE RADIOPAQUE SNARE MARKER WAS LEFT IN THE PATIENT. NO HEALTH CONSEQUENCES OR IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19750159 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem
IT WAS REPORTED WITH LIMITED INFORMATION THAT A GOOSENECK SNARE WAS INTENDED TO BE USED FOR PATIENT TREATMENT BUT WAS DAMAGED. THE PRODUCT WAS REPLACED TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE CATHETER WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19622021 ↗MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A GOOSENECK SNARE DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THE MARKER DETACHED FROM GOOSENECK CATHETER AND REMAINED IN A BRANCH OF PULMONARY ARTERY. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737506 ↗MalfunctionFeb 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A GOOSENECK SNARE DURING PATIENT TREATMENT. LITTLE VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION WERE REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE PROCEDURE WHILE TRYING TO SNARE A DOUBLE J STENT IN THE PATIENTS PROXIMAL URETER THE MARKER BAND FROM THE CATHETER BECAME DISLODGED AND FREE-FLOATING IN THE PATIENT¿S BODY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737323 ↗InjuryJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS ATTEMPTING TO USE A AMPLATZ GOOSENECK SNARE KIT 20MM, IT WAS REPORTED THAT IN PROCESS OF USING THE SNARE THE TIP BROKE OFF IN THE PATIENT. ANOTHER SNARE WAS USED AND SUCCESSFULLY RETRIEVED THE TIP WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18426683 ↗InjurySep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE GOOSENECK SNARE DURING TREATMENT OF PATIENTS UPPER LEFT QUADRANT OF CHEST. NO VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. IT WAS REPORTED THAT APPROXIMATELY 4 INCHES OF THE CATHETER TIP BROKE OFF IN UPPER LEFT QUADRANT OF PATIENT CHEST. PATIENT REQUIRED A CT AND A SECOND IR PROCEDURE VENOGRAM REMOVAL OF FOREIGN BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17718160 ↗MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A GOOSENECK SNARE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE SNARE BROKE DURING THE PROCEDURE. UNKNOWN IF THE SNARE DETACHED OR WHICH PART OF THE DEVICE BROKE. NO INTERVENTION NEEDED TO REMOVE THE DEVICE OR ANY PIECES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16002683 ↗MalfunctionDec 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A GOOSENECK SNARE DURING A GU CATHETER EXCHANGE PROCEDURE. IT WAS REPORTED THAT THE RADIOPAQUE TIP OF SNARE DEVICE DETACHED AND FELL INTO THE RENAL PELVIS. BY THE END OF THE EXAM, THE TIP HAD MOVED DOWN THE URETER, MIDWAY IN BETWEEN THE KIDNEY AND UROSTOMY. NO FURTHER PATIENT INFORMATION REPORTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15976252 ↗MalfunctionOct 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A GOOSENECK SNARE WAS USED FOR GASTRIC SURGERY. IT WAS REPORTED THAT THE RADIOPAQUE MARKER OF SNARE SHEATH WAS SEPARATED FROM THE SHEATH AND DROPPED IN THE DISTAL ARTERY OF GASTRIC. THE RADIOPAQUE MARKER WHICH IS DETACHED FROM SNARE SHEATH REMAINS IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15697196 ↗
Other Ev3, Inc products
All Ev3, Inc 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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