Reinforced Introducer Set for Sensation Plus & Mega 8Fr 0684-00-0403-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607567107943), received between May 10, 2023 and May 10, 2023 — classified as 1 injury.

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

2 FDA recall records 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 18, 2026.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2224-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Nov 20, 2019Class IITerminated

   Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

   Z-0934-2020 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Crack; Crack

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY ON A STEMI PATIENT, THE SHEATH CRACKED BY THE TRANSITION POINT. THE DILATOR SNAPPED CAUSING THE MAIN DILATOR TO STAY IN THE SHEATH. DR. (B)(6) INDICATED COUNTERPULSATION THERAPY WAS INTENDED TO ASSIST WITH RESUSCITATION EFFORTS, CONFIRMING THE GETINGE IAB WAS INTENDED TO BE INSERTED IN A FEMORAL ARTERY WITH ARTERIAL ACCESS. THE DEVICE WAS REPORTED TO BE WITHOUT OBVIOUS DEFECT UPON REMOVAL FROM KIT, AND ASSEMBLY OF THE SHEATH DILATOR INTO THE GETINGE PROVIDED SHEATH WAS UNEVENTFUL. FEMORAL ACCESS WAS OBTAINED AND SHEATH/DILATOR ASSEMBLY WAS PASSED OVER THE WIRE WITHOUT EVENT. WHEN REMOVING THE DILATOR AND WIRE TOGETHER, DR. O¿COCHLAIN DISCOVERED THAT ONLY THE DILATOR HUB REMAINED ON THE WIRE, THE DISTAL PORTION OF THE DILATOR REMAINING WITHIN THE SHEATH. ATTEMPTS TO PASS A WIRE TO RETRIEVE THE DILATOR REMAINING WITHIN THE SHEATH WERE UNSUCCESSFUL. THERE WAS REPORTEDLY SOME PATIENT MOVEMENT DURING THE PROCEDURE BUT TIMING OR SEVERITY OF THE MOVEMENT COULD NOT BE CONFIRMED. DR. O¿COCHLAIN CONFIRMED VESSEL INJURY DID OCCUR, DESCRIBED AS ¿INTERNAL ILIAC DISSECTION¿, THE TIP OF THE DILATOR MAKING CONTACT WITH THE VESSEL WALL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16903383 ↗