Cardiovascular Procedure Kit 70178-06Recalls & reported problems
Terumo Cardiovascular Systems Corporation
All models of Cardiovascular Procedure Kit (227)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753510265), received between May 17, 2021 and May 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (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 16, 2026.
Recalls naming this device
- Feb 20, 2024Class IIOpen, Classified
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
Z-1401-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Handling Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2021Material Rupture; Device Handling Problem; Material Rupture; Device Handling Problem
THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BOOT TUBING RUPTURED AT THE OUTLET SIDE OF THE ROLLER HEAD . THE CARDIOVASCULAR PROCEDURE KIT HAD BEEN SETUP AND PRIMED, AND LEFT RUNNING FOR APPROXIMATELY 72 HOURS PRIOR TO USE ON THE PATIENT. THE TOTAL BYPASS TIME WAS 59 MINUTES WITH A 46 MINUTE DHCA TIME. DURING DHCA, ROLLER HEAD WAS RUNNING AT APPROXIMATELY 100ML/MIN TO ALLOW FOR CONTINUOUS RECIRCULATION OF BLOOD. THE RUPTURE RESULTED IN APPROXIMATELY 50 CC OF BLOOD LOSS AND NO DELAY WAS REPORTED. THE PRODUCT WAS CHANGED OUT. ACCORDING TO THE PERFUSIONIST, CPB WAS ABLE TO BE TERMINATED AT THE TIME OF THE TUBING RUPTURE AND CPB WAS NOT RESUMED FOLLOWING THE INCIDENT. NO TRANSFUSION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11837637 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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