Sarns™ Cardioplegia Set 6375Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K900640); they may or may not involve this specific model.

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. 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K900640. One submission often covers many models, so check the product and lot details in each record.

• Z-0156-2015 · Mar 1, 2011 · Terminated
  Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed
• Z-2163-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032
• Z-2150-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246
• Z-2615-2010 · Jun 8, 2010 · Terminated
  Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03