Cardiovascular Procedure Kit 75927-01Recalls & 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00699753505940), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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, 2024Open, 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
- Incomplete or Inadequate Connection1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 8, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
PER MEDWATCH MW5106668 PROVIDED BY DEPT OF HEALTH & HUMAN SERVICES: "DURING EXTRACTION OF RIGHT PACER LEAD, MULTIPLE ADHESIONS WERE CREATING DIFFICULTY TO REMOVE. CARDIOLOGIST SOON PERFORATED THROUGH RIGHT ATRIA. CVT SURGEON NOTICED BLOOD PRESSURE DROPPING QUICKLY. CARDIOLOGIST REMAINED IN CASE TO ASSIST CVT SURGEON AND IMMEDIATE OPEN PROCEDURE BEGAN. THE PERFUSION PUMP WAS PREPARED WITH APPLICATION OF PUMP PACK. ARTERIAL/AORTIC CANNULA WAS PLACED. THE RIGHT ATRIUM WAS CANNULATED, LOWER FLOW SALINE INITIATED THROUGH ARTERIAL CANNULA LINES. VENOUS CANNULA PLACED. NEXT A LARGER VOLUME (BLOOD) STARTED TO FLOW THROUGH THE TUBING TO THE ARTERIAL CANNULA, AND THE TUBING POPS APART." THE TUBING THAT DISCONNECTED WAS THE BLOOD LINE OFF THE CARDIOPLEGIA CIRCUIT CONNECTING TO THE RECIRCULATION LINE COMING OFF THE ARTERIAL PORT OF THE OXYGENATOR. THE END THE CARDIOPLEGIA TUBING LINE WAS CONNECTED OVER A 1/4X1/4 BARBED STRAIGHT CONNECTOR BY THE PERFUSIONISTS AT THIS ACCOUNT AS PART OF THEIR SETUP. IT RESULTED TO 200ML OF BLOOD LOSS, BLOOD WAS RAPIDLY INFUSED AND CVT SURGEON WAS PERFORMING OPEN MASSAGE TO MAINTAIN BLOOD PRESSURE. AS SOON AS PUMP STARTED, THEY WENT ON BYPASS AND THE PERFUSIONIST
Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation
MAUDE report 13690618 ↗
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 16, 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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