Sensation 7Fr. 40cc IAB (China) 0684-00-0470-01CRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10607567109374), received between Jan 14, 2021 and Jul 7, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Difficult to Remove; Material Rupture

  ON (B)(6) 2026, THE PATIENT SUFFERED AN ACUTE MYOCARDIAL INFARCTION AND WAS IN CRITICAL CONDITION. AS A LIFE-SAVING MEASURE, AN INTRA-AORTIC BALLOON (IAB) WAS INSERTED. THE PROCEDURE WAS TECHNICALLY CHALLENGING BECAUSE ULTRASONOGRAPHY REVEALED SEVERE CALCIFICATION OF THE LOWER-EXTREMITY ARTERIES. UNDER ULTRASOUND GUIDANCE, THE IAB WAS EVENTUALLY INSERTED WITH CONSIDERABLE DIFFICULTY, RESULTING IN STABILIZATION OF THE PATIENT'S HEMODYNAMIC STATUS. THE PATIENT SUBSEQUENTLY UNDERWENT SUCCESSFUL CORONARY ARTERY BYPASS GRAFTING (CABG). ON (B)(6) 2026, DURING ATTEMPTED REMOVAL OF THE IAB, THE BALLOON BECAME ENTRAPPED WITHIN ATHEROSCLEROTIC PLAQUE AND COULD NOT BE WITHDRAWN THROUGH THE VASCULAR ACCESS ROUTE. VASCULAR SURGEONS AND GENERAL SURGEONS WERE CONSULTED, AND SURGICAL EXPLORATION OF THE ABDOMEN AND GROIN WAS PERFORMED WITH ARTERIOTOMY TO FACILITATE REMOVAL OF THE BALLOON. INTRAOPERATIVELY, THE ABDOMINAL AORTA AND COMMON ILIAC ARTERIES WERE FOUND TO BE SEVERELY CALCIFIED, WITH MARKED STENOSIS AND NEAR-COMPLETE OCCLUSION IN SOME SEGMENTS. DUE TO THE EXTENSIVE VASCULAR CALCIFICATION AND UNFAVORABLE ANATOMY, COMPLETE RETRIEVAL OF THE DEVICE WAS NOT POSSIBLE. CONSEQUENTLY, A SMALL STERI

  Patient problems: Foreign Body In Patient; Insufficient Information; Ischemia

  MAUDE report 25729827 ↗
• MalfunctionFeb 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT, WHILE USING SENSATION 7FR. 40CC INTRA-AORTIC BALLOON PUMP (IABP), THE PATIENT'S ELECTROCARDIOGRAM (ECG) WAS PACING ABNORMALITIES AND UNABLE TO PERFORM PACING; SIMULTANEOUSLY, DUE TO THE FIBER OPTIC FAILURE, THE IABP COULD NOT PROVIDE NORMAL COUNTERPULSATION. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430439 ↗
• MalfunctionMar 27, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT INTRA AORTIC BALLOON (IAB) FIBER OPTIC WAS NOT WORKING EVEN AFTER CHECKED ON TWO MACHINES.

  Patient problems: Insufficient Information

  MAUDE report 21706631 ↗
• 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 RECORD IS FOR THE 2ND IAB USED. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE 1ST IAB UNDER MFG REPORT NUMBER 2248146-2023-00245.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707757 ↗
• MalfunctionFeb 20, 2023Inappropriate Waveform; Optical Problem; Pressure Problem; Inappropriate Waveform; Optical Problem; Pressure Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404531 ↗
• MalfunctionJan 10, 2023Calibration Problem; Calibration Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133902 ↗
• MalfunctionDec 20, 2022Material Deformation; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017978 ↗
• MalfunctionJan 14, 2021Optical Problem; Optical Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE OPTICAL FIBER PRESSURE SIGNAL IS SOMETIMES NOT AVAILABLE. THE IAB WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11169713 ↗