Linear 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0480-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10607567109527), received between Jan 26, 2021 and Apr 24, 2025 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE INTRA-AORTIC BALLOON(IAB) RN CALLS TO REPORT AN INCIDENT THAT OCCURRED 2 DAYS AGO. SHE REPORTS A LINEAR 40CC IAB WAS SEEN WITH BLOOD IN THE HELIUM TUBING. SHE STATES THE BLOOD DID NOT GET INTO THE CS300 AND WAS CONTAINED NEAR THE WHITE ¿Y¿ FITTING. SHE STATES THEY DC¿D THERAPY AND CLAMPED THE TUBING FOR IAB REMOVAL. THE IAB WAS AN AXILLARY PLACEMENT THAT WAS INDWELLING THE PATIENT FOR 15 DAYS. SHE STATES THERE IS NO HARM TO THE PATIENT DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897493 ↗
• DeathMar 10, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) EXPERIENCED A CATHETER RUPTURE. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE.

  Patient problems: Insufficient Information

  MAUDE report 21558018 ↗
• InjuryMar 25, 2024

  REGISTERED NURSE (RN) MONITORING PATIENT WITH RIGHT FEMORAL BALLOON PUMP IN PLACE. MACHINE ALARMED THAT IT WAS IN STANDBY, AS WELL AS FOR LOSS OF GAS. RN ASSESSED BALLOON TUBING AND FOUND BLOOD SPECKS TO BE THROUGHOUT THE TUBING. CLAMPED TUBING IMMEDIATELY AND NOTIFIED PROVIDER OF RUPTURE. PATIENT HAD TO UNDERGO EXPEDITE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18967808 ↗
• MalfunctionOct 5, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED THE INTRA-AORTIC BALLOON (IAB) WITH THE PACKAGING DAMAGED. THE CUSTOMER WAS CONCERNED ABOUT THE STERILE BARRIER BEING COMPROMISED SO THEY DID NOT USE THE DEVICE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576888 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  DURING THE INVESTIGATION OF THE RETURNED INTRA-AORTIC BALLOON (IAB) INVOLVED UNDER MFG REPORT NUMBER 2248146-2021-00043, A KINK WAS FOUND THAT WAS UNRELATED TO THE REPORTED LEAK, BALLOON RUPTURE FAILURE MODE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526351 ↗
• MalfunctionJan 26, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A BALLOON RUPTURE OCCURRED. THE IAB WAS REMOVED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11228912 ↗