Stent FREDX5532-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429114490), received between Nov 14, 2022 and Dec 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Activation Failure” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Sep 5, 2025Open, Classified

   Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

   Z-0108-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING TREATMENT FOR A LEFT ICA ANEURYSM, THE STENT WAS NAVIGATED THROUGH THE MICROCATHETER TO THE DISTAL LANDING ZONE. DISTAL DIAMETER MEASURED 4.07MM, PROXIMAL DIAMETER MEASURED 5.1MM, LENGTH FROM LANDING ZONE TO LANDING ZONE MEASURED 24MM. THE STENT WOULD NOT OPEN DISTALLY WHEN CROSSING THE NECK OF THE ANEURYSM, AND IT STARTED HERNIATING INTO THE ANEURYSM. THE STENT WAS RECAPTURED. WHEN DEPLOYING AGAIN, THE PHYSICIAN PERFORMED THE DEPLOYMENT DIFFERENTLY, SO THE STENT DID NOT HERNIATE AS MUCH. HOWEVER, THE STENT DID NOT OPEN FULLY ACROSS THE ANEURYSM. THE STENT WAS RECAPTURED AND WAS REDEPLOYED AGAIN. THE STENT DID OPEN PROXIMALLY, BUT IT DID NOT OPEN ACROSS THE ANEURYSM. MANIPULATION OF THE STENT WAS ATTEMPTED TO GET IT OPENED ACROSS THE NECK OF THE ANEURYSM. AFTER POST DEPLOYMENT, THERE WAS A DELAYED FILL IN THE VESSELS AS THE STENT WAS CONSTRAINED AND WAS NOT FULLY OPENED. PHYSICIAN CHOSE TO ANGIOPLASTY DEVICE WITH AN APEX BALLOON AND WAS ABLE TO CROSS THROUGH AND ANGIOPLASTY. POST ANGIOPLASTY, THE INTERMEDIATE CATHETER WAS ABLE TO CROSS THROUGH THE DEVICE. POST PROCESSING RUN WAS DONE, AND FLOW WAS BETTER, BUT STILL SLUGGISH. ANGIOPLASTY WAS DONE AGAIN, B

  Patient problems: Reduced Blood Flow; Vascular Dissection

  MAUDE report 20921744 ↗
• InjuryNov 14, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE FRED X STENT DID NOT OPPOSE COMPLETELY ON THE DISTAL PORTION OF THE WALL, AND THE MIDDLE SECTION OF THE STENT DID NOT FULLY OPEN. A BALLOON ANGIOPLASTY WAS PERFORMED ON BOTH THE DISTAL AND MIDDLE SEGMENT, AND THE MIDDLE SECTION OF THE STENT OPENED BETTER AS A RESULT. THE PATIENT WAS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795279 ↗