Stealth® Spring Clip A1603Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00607915110581), received between Nov 4, 2019 and Jan 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 7, 2020Defective Component; Defective Component

  COMPLAINT 1 OF 2: (B)(4)- CLIP 1. COMPLAINT 2 OF 2: (B)(4)- CLIP 2. PROCEDURE PERFORMED: HEART PROCEDURE. LIMITED INFORMATION AVAILABLE AT THE TIME OF THE REPORT. IN THE MIDDLE OF THE PROCEDURE THEY WERE TRYING TO PLACE 2 STEALTH SPRING CLIPS AND THEY WOULD NOT STAY CLOSED. THESE CLIPS WERE REMOVED. THEY PULLED 2 MORE CLIPS FROM ANOTHER LOT NUMBER, THESE DID STAY CLOSED AND CASE COMPLETED. THERE WAS NO DAMAGE TO THE VESSEL. THERE WAS NO LOSS OF OCCLUSION DUE TO THE CLIPS NOT STAYING CLOSED. THE CLIPS ARE AVAILABLE FOR RETURN. INTERVENTION: REPLACED WITH NEW CLIP OF A DIFFERENT LOT NUMBER. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561727 ↗
• MalfunctionJan 7, 2020Defective Component; Defective Component

  COMPLAINT 1 OF 2: (B)(4) - CLIP 1. COMPLAINT 2 OF 2: (B)(4) - CLIP 2. PROCEDURE PERFORMED: HEART PROCEDURE. LIMITED INFORMATION AVAILABLE AT THE TIME OF THE REPORT. IN THE MIDDLE OF THE PROCEDURE THEY WERE TRYING TO PLACE 2 STEALTH SPRING CLIPS AND THEY WOULD NOT STAY CLOSED. THESE CLIPS WERE REMOVED. THEY PULLED 2 MORE CLIPS FROM ANOTHER LOT NUMBER, THESE DID STAY CLOSED AND CASE COMPLETED. THERE WAS NO DAMAGE TO THE VESSEL. THERE WAS NO LOSS OF OCCLUSION DUE TO THE CLIPS NOT STAYING CLOSED. THE CLIPS ARE AVAILABLE FOR RETURN. INTERVENTION: REPLACED WITH NEW CLIP OF A DIFFERENT LOT NUMBER. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561719 ↗
• MalfunctionNov 13, 2019Defective Component; Defective Component

  PROCEDURE PERFORMED: CORONARY ARTERY BYPASS GRAFTING (CABG) "CONFIDENTIAL REPORT NAME: 4600210000-2019-8048 UID: 048." "EVENT TITLE: VASCULAR CLAMP FAILED." THE EVENT OCCURRED ON 10/13/2019. THE FACILITY WAS AWARE OF THIS EVENT LESS THAN OR EQUAL TO 10 DAYS AGO. THE DATE OF THIS REPORT IS 10/23/2019. THIS EVENT OCCURRED AT A HOSPITAL IN THE OPERATING ROOM. "THE DEVICE(S) MAY HAVE CAUSED OR CONTRIBUTED TO: POTENTIAL FOR PATIENT HARM." THERE WAS A PROBLEM WITH THE DEVICE (SUCH AS A DEFECT, MALFUNCTION, BREAK, ETC.). THE PROBLEMS THAT THE USER HAD WERE: "DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)" AND "DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." REGARDING IF THERE WERE OTHER THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, IT IS NOT APPLICABLE. "DESCRIBE THE EVENT OR PROBLEM: A DISPOSABLE VASCULAR CLAMP THAT IS USED FOR INTERNAL MAMMARY GRAFTS ON CABG PATIENTS FAILED. LOT DEFECTIVE? THIS HAS HAPPENED MULTIPLE TIMES BEFORE. THIS TIME WE WERE ABLE TO LOCATE THE LOT # ANEW ONE WAS OBTAINED." THE DEVICE IS EXPECTED TO RETURN. ADDITIONAL INFORMATION WAS RECEIVED FR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9319446 ↗
• MalfunctionNov 4, 2019Defective Component

  A DISPOSABLE VASCULAR CLAMP THAT IS USED FOR INTERNAL MAMMARY GRAFTS ON CABG PATIENTS FAILED. DEFECTIVE LOT? THIS HAS HAPPENED MULTIPLE TIMES BEFORE. THIS TIME WE WERE ABLE TO LOCATE THE LOT NUMBER. A NEW ONE WAS OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9271446 ↗