Sarns™ Cardioplegia Set 16010Recalls & 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.

14 other recalls cover devices cleared under the same FDA submission (K823451); 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 K823451. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2015 · Mar 1, 2011 · Terminated
  Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart
• Z-2152-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01
• Z-2160-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846
• Z-2151-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK P/N 65503/70881-02
• Z-2149-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937
• Z-2162-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01
• Z-2158-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA P/N 72642
• Z-2157-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934
• Z-2159-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790
• Z-2155-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733
• Z-2161-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02
• Z-2156-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP
• Z-2154-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01
• Z-2153-2010 · Jun 8, 2010 · Terminated
  Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01