Sensation 7Fr. 34cc IAB (China) 0684-00-0469-01CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10607567109367), received between Dec 2, 2020 and May 23, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (3 reports).

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 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-2217-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionMay 23, 2023Optical Problem; Pressure Problem; Optical Problem; Pressure Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY FOUR DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY, THE CONSOLE GENERATED A FIBER OPTIC SENSOR FAILURE ALARM. THE CUSTOMER COULD NOT MONITOR THE PRESSURE WAVEFORM. THE IAB WAS THEN REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985136 ↗
• MalfunctionApr 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTING THE INTRA-AORTIC BALLOON (IAB), BLOOD WAS SEEN IN THE TUBING. A NEW IAB WAS THEN INSERTED TO CONTINUE THERAPY, BUT THE SAME ISSUE OCCURRED AND BLOOD WAS SEEN IN THE TUBING AGAIN. THE PATIENT WAS THEN TREATED USING MEDICATION INSTEAD OF IAB THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED. THIS REPORT IS FOR THE 1ST IAB USED. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE 2ND IAB UNDER MFG REPORT NUMBER 2248146-2023-00249.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707515 ↗
• MalfunctionFeb 20, 2023Inappropriate Waveform; Optical Problem; Pressure Problem; Inappropriate Waveform; Optical Problem; Pressure Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY FIVE DAYS OF INTRA-AORTIC BALLOON (IAB) THERAPY THE CONSOLE GENERATED A FIBER OPTIC SENSOR FAILURE ALARM AND DID NOT DISPLAY THE PRESSURE WAVEFORM. THE CUSTOMER ATTEMPTED TO RECONNECT THE FIBER OPTIC CABLE BUT THIS DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE PROVIDED PRESSURE TUBING WAS NOT USED. THEY THEN UTILIZED THE FLUID-FILLED TRANSDUCER TO OBTAIN THE PRESSURE AND CONTINUED THERAPY. THE IAB WAS REMOVED AFTER APPROXIMATELY SEVEN DAYS OF THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404425 ↗
• MalfunctionDec 20, 2022Optical Problem; Pressure Problem; Optical Problem; Pressure Problem

  IT WAS REPORTED THAT AFTER SEVERAL HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, A FIBER OPTIC SENSOR FAILURE OCCURRED AND THE PRESSURE COULD NOT BE OBTAINED. HOWEVER, THERAPY WAS CONTINUED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015210 ↗
• MalfunctionDec 2, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER APPROXIMATELY EIGHT HOURS OF INTRA-AORTIC BALLOON (IAB) THERAPY, BLOOD WAS NOTICED IN THE TUBING. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10934668 ↗