Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China) 0684-00-0568-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10607567109442), received between Sep 2, 2025 and Jan 21, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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-2221-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Device Sensing Problem

  IT WAS REPORTED BY THE CUSTOMER THROUGH EMERGENCY SUPPORT PROGRAM THAT THE SENSATION PLUS 40CC HAD FIBER-OPTIC SENSOR FAILURE ALARM ON A CARDIOSAVE DURING USE. NURSE DENIED ANY KINK OR FOLD IN THE FO CABLE AND STATED THAT HE HAD ALREADY UNPLUGGED AND RE PLUGGED THE FO SENSOR CABLE ONCE BEFORE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128063 ↗
• MalfunctionNov 7, 2025Restricted Flow rate; Device Sensing Problem; Restricted Flow rate; Device Sensing Problem

  THE COMPLAINT WAS RECEIVED THROUGH A DIRECT CALL FROM THE CUSTOMER TO THE EMERGENCY SUPPORT PROGRAM. NO HARM OR INJURY TO THE PATIENT WAS REPORTED. IT WAS REPORTED BY CUSTOMER THAT DURING USE THE SENSATION PLUS 40CC INTRA-AORTIC BALLOON (IAB) HAD A FIBER OPTIC SENSOR FAILURE ALARM AND AN IAB CATHETER RESTRICTION ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497356 ↗
• MalfunctionSep 2, 2025Inability to Auto-Fill; Device Sensing Problem; Gas/Air Leak; Optical Problem; Inability to Auto-Fill; Device Sensing Problem; Gas/Air Leak; Optical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939567 ↗