Suction tip SU-xxxxx (UDI 00803622105913)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00803622105913), received between Nov 1, 2018 and Jun 1, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Disconnection” (8 reports).

10 other recalls cover devices cleared under the same FDA submission (K982891); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  SEE INTIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038522 ↗
• MalfunctionJan 10, 2023Disconnection; Disconnection

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129728 ↗
• MalfunctionJul 25, 2022Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  LIVANOVA USA RECEIVED A REPORT OF ATRASUMP TIP DISCONNECTION DURING A PROCEDURE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15091548 ↗
• MalfunctionMay 11, 2022Disconnection; Disconnection

  LIVANOVA USA RECEIVED A REPORT OF ATRASUMP TIP DISCONNECTION DURING ITS PLACEMENT IN THE HEART. THERE IS NO REPORT OF ANY PATIENT INJURY. ADDITIONALLY, IT WAS REPORTED THAT IN ANOTHER ATRASUMP CANNULA BELONGING TO THE SAME ITEM CODE DISCONNECTED FROM THE CANNULA BODY DURING MANIPULATION OF THE CANNULA TO POSITION IN THE HEART BEFORE STARTING THE PROCEDURE. THE SECOND UNIT HAS BEEN DISPOSED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352258 ↗
• MalfunctionMar 3, 2022Disconnection; Disconnection

  LIVANOVA USA RECEIVED A REPORT OF ATRASUMP TIP DISCONNECTION DURING A PROCEDURE. THE TIP WAS RECOVERED IN THE PATIENT'S HEART DURING THE SURGERY.THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658112 ↗
• MalfunctionDec 15, 2021Disconnection; Disconnection

  LIVANOVA USA RECEIVED A REPORT OF ATRASUMP TIP DISCONNECTION DURING A PROCEDURE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010723 ↗
• MalfunctionNov 15, 2021Disconnection; Disconnection

  LIVANOVA USA RECEIVED A REPORT OF ATRASUMP TIP DISCONNECTION DURING A PROCEDURE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12809044 ↗
• MalfunctionDec 4, 2019Disconnection; Disconnection

  SEE INTIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9408780 ↗
• MalfunctionNov 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  LIVANOVA RECEIVED A REPORT THAT THE TIP OF AN RIGID TIP SUCTION WAND USED DURING A MINIMALLY-INVASIVE VALVE REPAIR PROCEDURE ON (B)(6), 2018 WAS RETAINED IN THE PATIENT'S CHEST IN THE RIGHT PLEURAL CAVITY, CONFIRMED BY X-RAY, AFTER THE PROCEDURE. THE PATIENT UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2018 TO REMOVE THE DEVICE. THE TIP WAS REMOVED WITHOUT COMPLICATION VIA THE EXISTING INCISION. THE TIP WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982891. One submission often covers many models, so check the product and lot details in each record.

• Z-0650-2013 · Nov 2, 2012 · Terminated
  Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction
• Z-0649-2013 · Nov 2, 2012 · Terminated
  Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
• Z-2046-2009 · Feb 5, 2008 · Terminated
  Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113.
• Z-1310-2008 · Jan 29, 2008 · Terminated
  Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table
• Z-1312-2008 · Jan 29, 2008 · Terminated
  Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. ( Pump & table pack contains a weighted flexible
• Z-1313-2008 · Jan 29, 2008 · Terminated
  Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible
• Z-1311-2008 · Jan 29, 2008 · Terminated
  Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted fl
• Z-1176-2008 · Jan 24, 2008 · Terminated
  CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626
• Z-1177-2008 · Jan 24, 2008 · Terminated
  CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
• Z-1175-2008 · Jan 24, 2008 · Terminated
  CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626