Suction tip SU-xxxxx (UDI 00803622105814)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622105814), received between Jul 19, 2017 and Nov 27, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  LIVANOVA RECEIVED A REPORT THAT A RIGID TIP SUCTION WAND WAS FOUND TO BE MISSING THE TIP FOLLOWING CARDIAC SURGERY. THE CARDIAC TEAM SEARCHED FOR THE TIP IN THE CHEST OF THE PATIENT AND PERFORMED SEVERAL DIAGNOSTIC TESTS. THE TIP WAS UNABLE TO BE LOCATED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108328 ↗
• MalfunctionJul 19, 2017Detachment Of Device Component; Detachment Of Device Component

  SORIN GROUP RECEIVED A REPORT THAT THE SUCTION NOZZLE OF THE RIGID TIP SUCTION WAND DISCONNECTED FROM THE HANDLE WHILE SUCTIONING THE PLEURAL FLUID DURING A PROCEDURE AND FELL INSIDE THE PATIENT'S CHEST CAVITY. THE TIP WAS RECOVERED QUICKLY AND REMOVED FROM THE PATIENT WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726431 ↗

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-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-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-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-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