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Connector (UDI 00803622123313)Recalls & reported problems

Livanova USA, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622123313), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flare or Flash” (1 report).

22 other recalls cover devices cleared under the same FDA submission (K833322); 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

Device problems

  • Flare or Flash1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 11, 2019Flare or Flash; Flare or Flash

    SEE INITIAL REPORT.

    Patient problems: No Patient Involvement

    MAUDE report 9179546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K833322. One submission often covers many models, so check the product and lot details in each record.

  • Z-2454-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
  • Z-2458-2020 · Apr 24, 2020 · Terminated
    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
  • Z-2445-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
  • Z-2462-2020 · Apr 24, 2020 · Terminated
    1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
  • Z-2460-2020 · Apr 24, 2020 · Terminated
    3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
  • Z-2449-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
  • Z-2448-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
  • Z-2456-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
  • Z-2447-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
  • Z-2461-2020 · Apr 24, 2020 · Terminated
    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
  • Z-2452-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
  • Z-2450-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
  • Z-2446-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
  • Z-2459-2020 · Apr 24, 2020 · Terminated
    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
  • Z-2451-2020 · Apr 24, 2020 · Terminated
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276

…and 7 more.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.