OPTEASE 466C210FRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032009369), received between May 1, 2018 and Jan 7, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING THE RECOVERY OPERATION OF A VENA CAVA FILTER THE HEAD-END OF A 10F OPTEASE RETRIEVAL CATHETER WAS USED, HOWEVER UPON ENTERING THE THIGH VEIN OF THE PATIENT¿S BODY IT WAS FOUND OUT THAT THE CATHETER FELL OFF UNDER FLUOROSCOPY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THE INDICATION FOR FILTER INSERTION WAS DEEP VEIN THROMBOSIS (DVT). WHEN THE RETRIEVAL OF THE CATHETER ENTERED THE PATIENT, THE EVENT OCCURRED AT FEMORAL VEIN. THE DEVICE WAS WITHDRAWN FROM THE PATIENT USING A NON-CORDIS CATHETER. AN IMAGE WAS AVAILABLE FOR REVIEW. THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS CONTAINING AN INTACT CATHETER AND A COMPLAINT CATHETER WITH HEAD TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560967 ↗
• InjuryNov 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE BLUE RING AT THE FAR-END OF 10F OPTEASE RETRIEVAL CATHETER FELL OFF AFTER THE RECOVERY WHILE USING OPTEASE FILTER. THE RING WAS REMOVED BY USING THE UNKNOWN GUIDE WIRE AND THE CATHETER UNDER THE BLOCKAGE OF THE BALLOON. THERE WAS NO ANY PATIENT INJURY AND THE PATIENT¿S OUTCOME WAS GREAT. THIS WAS A CASE OF THE REMOVAL OF INFERIOR VENA CAVA FILTER. THERE WERE NO ANOMALIES OF THE PATIENT`S VESSELS. THERE WAS NO VESSEL TORTUOSITY. THE DEVICE WAS STORED AS PER THE LABELING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO ANY DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE DEVICE WAS NOT IN AN ACUTE BEND. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED. AVAILABLE IMAGES WERE REVIEWED. IN THE FIRST IMAGE AN X-RAY IMAGE SHOWS AN INFLATED BALLOON, A SNARE DEVICE IN A GUIDE CATHETER AND A CYLINDRICAL RADIOPAQUE OBJECT THAT MAY BE THE TIP OF A CATHETER. THERE IS A GRADUATED MARKER ADJACENT, LIKELY LOCATED ON THE SURFACE OF THE DRAPE. THE IMAGE APPEARS TO BE IN THE REGION OF THE PELVIS. THE SEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285716 ↗
• MalfunctionJun 10, 2019Crack; Crack

  AS REPORTED, THE TIP-END OF TWO 10F OPTEASE RETRIEVAL CATHETERS WERE NOTED TO BE FRACTURED, WHEN THE CATHETER WAS BEING FLUSHED BEFORE USE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE PACKAGING OF THE DEVICE AND THE DEVICES WERE PREPPED AS PER THE IFU. THERE WAS NO UNUSUAL FORCE USED AT ANYTIME. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682310 ↗
• MalfunctionJun 10, 2019Crack; Crack

  AS REPORTED, THE TIP-END OF TWO 10F OPTEASE RETRIEVAL CATHETERS WERE NOTED TO BE FRACTURED, WHEN THE CATHETER WAS BEING FLUSHED BEFORE USE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE STORED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED TO THE PACKAGING OF THE DEVICE AND THE DEVICES WERE PREPPED AS PER THE IFU. THERE WAS NO UNUSUAL FORCE USED AT ANYTIME. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682282 ↗
• InjuryMay 1, 2018Detachment Of Device Component; Difficult to Remove; Detachment Of Device Component; Difficult to Remove

  AS REPORTED, DURING THE OPERATION, THE YELLOW TIP OF THE OPTEASE RETRIEVAL CATHETER FELL OFF IN THE PATIENT'S BODY. ADDITIONAL INFORMATION WAS RECEIVED AND THERE WAS DIFFICULTY WITHDRAWING THE DEVICE. THE TIP OF THE DEVICE WAS NOT RETRIEVED; THE PATIENT SEEMED IN NORMAL CONDITION. THE TARGET LESION IS THE INFERIOR VENA CAVA AND THE PROCEDURE IS FOR EMBOLISM. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE WAS PREPPED ACCORDING TO THE INSTRUCTION FOR USE (IFU) WITH NO ANOMALIES NOTED DURING PREP. THERE WERE NO DIFFICULTY TRACKING THE DEVICE TOWARDS THE LESION. THERE WERE NO DIFFICULTY CROSSING THE LESION. THERE WERE NO KINKS OBSERVED ON THE DEVICE. THERE WERE NO EXCESSIVE FORCE USED DURING THE PROCEDURE. THERE IS NO PROCEDURAL VIDEO AVAILABLE. THE DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7476463 ↗