SaddleLoop 18g x 10cm with Blunt Needle 1541Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20634624015412), received between Dec 28, 2016 and Nov 8, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2017Detachment Of Device Component; Detachment Of Device Component

  THE FOREIGN DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WHILE USING THE SADDLELOOP VASCULAR SNARE. THE REPORT STATED THAT THE ELASTIC TAPE (TUBE) WASN'T LOCKED INTO THE SLOT OF THE KEYHOLE, AND THE TENSIONER WAS COMING OFF FROM THE TUBE. THE REPORT STATED ANOTHER PACKAGE OF SADDLELOOP WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE SURGERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011807 ↗
• MalfunctionNov 8, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Failure To Adhere Or Bond

  A REPORT WAS RECEIVED FROM THE DISTRIBUTOR IN (B)(4). THE REPORT STATES THAT THE TENSIONER ON THE SADDLELOOP CAME OFF FROM THE TUBE IN TWO SEPARATE PROCEDURES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011800 ↗
• MalfunctionApr 5, 2017Detachment Of Device Component

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED WITH THE SADDLELOOP DEVICE DURING USE. THE CLINICIAN REPORTED THAT THE TENSIONER CAME OFF THE TUBING. THE REPORT STATED ANOTHER PACKAGE OF THE SAME DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS DISCARDED AND NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6460328 ↗
• MalfunctionDec 28, 2016Detachment Of Device Component; Loose or Intermittent Connection

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED WITH THE SADDLELOOP DEVICE DURING USE. THE CLINICIAN REPORTED THAT THE TUBING WAS NOT LOCKED INTO THE SLOT OF THE KEYHOLE AS EXPECTED. THE LOCKING MECHANISM WAS DETACHED FROM THE TUBING AND WAS LOOSE IN THE PACKAGE. THE REPORT STATED ANOTHER PACKAGE OF THE SAME DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6210153 ↗