Suction tip SU-xxxxx (UDI 00803622105883)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622105883), received between May 10, 2023 and May 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Restricted Flow rate; Restricted Flow rate

  LIVANOVA USA RECEIVED A REPORT OF A MALFUNCTION WITH A LIVANOVA SUCTION TIP CATHETER SUMPS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009352 ↗
• MalfunctionMay 10, 2023Crack; Crack

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901973 ↗

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-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-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-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-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-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-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-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-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-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