Connector (UDI 00803622129315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00803622129315), received between May 20, 2021 and May 20, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 reports).

18 other recalls cover devices cleared under the same FDA submission (K981613); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  LIVANOVA USA INC RECEIVED A REPORT THAT CATALOGUE ITEM # EC2140S 1/4X3/8 REDUCING CONNECTOR IS OCCLUDED AND CANNOT FLOW THROUGH IT DURING PRIMING. IN TOTAL OF 3 UNITS ARE AFFECTED HOWEVER ONLY 1 UNIT WILL BE RETURNED. THE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14453117 ↗
• MalfunctionOct 28, 2021Material Deformation; Material Deformation

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714555 ↗
• MalfunctionOct 28, 2021Material Deformation; Material Deformation

  LIVANOVA USA INC RECEIVED A REPORT THAT A 1/4 X 3/8 CONNECTOR USED TO ATTACH TUBING IN THE CIRCUIT WAS COMPLETELY OCCLUDED. THE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714554 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  LIVANOVA INC HAS RECEIVED A REPORT THAT A 1/4 X 3/8 CONNECTOR ASSEMBLED IN THE BYPASS CIRCUIT TO SELL SAVER HAD A MANUFACTURING DEFECT INSIDE THE CONNECTOR. THE ISSUE WAS OBSTRUCTING FLOW AND CAUSING HIGH PRESSURE IN THE ARTERIAL BYPASS LINE.THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853867 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  LIVANOVA INC HAS RECEIVED A REPORT THAT A 1/4 X 3/8 CONNECTOR HAD A REDUCTION ON TUBE SIZE DUE TO PIECE OF PLASTIC CAUSING BLOOD FLOW REDUCTION WHILE TRYING TO PERFUSE ON PUMP. THE CUSTOMER WAS NOT SURE IF PLASTIC WAS LOOSE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853866 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981613. One submission often covers many models, so check the product and lot details in each record.

• Z-1389-2020 · Jul 3, 2019 · Terminated
  LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion
• Z-0664-2018 · Dec 19, 2017 · Terminated
  Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
• Z-2796-2017 · Jun 29, 2017 · Terminated
  NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
• Z-2784-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
• Z-2794-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
• Z-2789-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
• Z-2786-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
• Z-2798-2017 · Jun 29, 2017 · Terminated
  NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
• Z-2790-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
• Z-2797-2017 · Jun 29, 2017 · Terminated
  NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
• Z-2793-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
• Z-2791-2017 · Jun 29, 2017 · Terminated
  STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
• Z-2787-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
• Z-2792-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
• Z-2783-2017 · Jun 29, 2017 · Terminated
  SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA

…and 3 more.