Linear 7.5Fr. 25cc IAB 0684-00-0478-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10607567106526), received between Oct 23, 2020 and Jan 24, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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-2223-2023 · 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.

• MalfunctionJan 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) LEAK OCCURRED DURING THERAPY. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THE IAB HAD BEEN INSERTED ON (B)(6) 2023. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT A METHOD DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18576041 ↗
• MalfunctionFeb 14, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371362 ↗
• MalfunctionDec 19, 2022No Apparent Adverse Event; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008773 ↗
• MalfunctionOct 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 11 DEVICES HAD A VAPOR-LIKE SUBSTANCE INSIDE THE INTRA-AORTIC BALLOON (IAB) INSERTION KIT. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS REPORT IS FOR #4 OF THE 11 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634915 ↗
• MalfunctionOct 3, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE PATIENT WAS GETTING READY FOR AN X-RAY AT THE BED SIDE. ALL OF A SUDDEN, THE GAS EXTENSION OF THE IAB BECAME FILLED WITH BLOOD. THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) GENERATED A BLOOD DETECTED ALARM AND THE IAB WAS REMOVED. THE PATIENT WAS WAITING FOR SURGERY THE NEXT DAY, BUT WAS IN STABLE CONDITION. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15530399 ↗
• MalfunctionAug 6, 2021Off-Label Use; Defective Component; Off-Label Use; Defective Component

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, THE CUSTOMER WAS CHANGING THE FLUSH LINE TUBING PER THEIR PROTOCOL WHEN THE STOPCOCK BROKE. THIS RESULTED IN THE LINE CLOTTING OFF AS THE PROBLEM WAS NOT REMEDIED QUICKLY. THE INSERTION WAS REPORTED TO BE AXILLARY, WHICH IS NOT THE METHOD DESCRIBED IN THE DEVICE INSTRUCTIONS FOR USE. THE CUSTOMER WAS MADE AWARE OF THE OFF-LABEL USE. THE CUSTOMER WAS THEN NOTIFIED OF THE NEED FOR THE ARTERIAL PRESSURE WAVEFORM ON THE CONSOLE AND THE MANY OPTIONS OF HOW TO OBTAIN IT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291818 ↗
• MalfunctionOct 23, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSERTION OF AN INTRA-AORTIC BALLOON (IAB), THE GUIDE WIRE WAS OBSTRUCTED. THE CUSTOMER ALSO NOTED FOREIGN PARTICLES ON THE DEVICE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10727694 ↗
• MalfunctionOct 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING INSERTION OF AN INTRA-AORTIC BALLOON (IAB), THE GUIDE WIRE WAS OBSTRUCTED. THE CUSTOMER ALSO NOTED FOREIGN PARTICLES ON THE DEVICE. THERE WAS NO PATIENT HARM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10727691 ↗