Suction tip SU-xxxxx (UDI 00803622105876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00803622105876), received between Dec 14, 2018 and Dec 21, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Crack; Off-Label Use; Crack; Off-Label Use

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18371858 ↗
• MalfunctionJul 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  LIVANOVA USA RECEIVED A REPORT THAT, FOLLOWING AN EVENT OF TIP DISCONNECTION, THE MEDICAL TEAM MANUALLY TESTED TWO ATRASUMP ITEM SU-29602 FROM THE SHELF AND NOTED THAT WERE ABLE TO PULL THE TIPS OFF THE CANNULAE WITHOUT TOO MUCH MANUAL FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15011648 ↗
• InjuryMay 23, 2022Material Integrity Problem; Material Integrity Problem

  LIVANOVA USA RECEIVED A REPORT THAT DURING HEART SURGERY, THE WIRE COIL ON END OF SUCTION SUMP SUCKER BECAME ENTANGLED IN MITRAL VALVE CORDAE. WIRE COIL HAD TO BE CUT TO BE REMOVED. SURGERY COMPLETION WAS DELAYED, AND NO PATIENT INJURY IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467915 ↗
• InjuryApr 14, 2022Material Integrity Problem; Material Integrity Problem

  LIVANOVA USA RECEIVED A REPORT THAT DURING HEART SURGERY, PART OF THE MITRAL VALVE GOT STUCK IN THE CANNULA SPRING. THE SURGEON HAD TO CUT THE CANNULA AND REMOVE IT IN PIECES TO AVOID DAMAGING THE VALVE. ACCORDING TO THE SURGEON, THE EXTRACORPOREAL CIRCULATION PROCEDURE WAS PROLONGED OF 35 MINUTES AND REQUIRED A LEFT ATRIOTOMY. THE PATIENT SHOWED MITRAL INSUFFICIENCY, ACCORDING TO THE CUSTOMER THIS COULD HAVE BEEN CAUSED BY THE LESION OF THE SUBVALVULAR MITRAL APPARATUS. THE MEDICAL TEAM CONSIDERED PATIENT STATUS NOT SEVERE AND THAT IT DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: Perforation of Vessels

  MAUDE report 14110062 ↗
• InjuryApr 12, 2022Material Integrity Problem; Material Integrity Problem

  LIVANOVA USA RECEIVED A REPORT THAT DURING HEART SURGERY, THE SUCTION SUMP CANULAE GRIPPED THE VALVULAE CORDS. PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14084535 ↗
• MalfunctionDec 14, 2018Particulates; Particulates

  LIVANOVA RECEIVED A REPORT THAT MULTIPLE RIGID TIP SUCTION WANDS WERE IDENTIFIED TO HAVE FOREIGN BODIES. IT IS UNCLEAR FROM THE PHOTOGRAPHS AND INFORMATION PROVIDED IF THE FOREIGN BODIES WERE INK MARKINGS OR PARTICLES, AND WHETHER THEY WERE INSIDE OR OUTSIDE OF THE CANNULA TUBING. THIS ISSUE WAS DISCOVERED DURING INCOMING INSPECTION AT THE DISTRIBUTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8166705 ↗

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-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-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-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-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
• 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