Intracardiac Sucker S351-70Recalls & reported problems
Sorin Group Italia Srl · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 08033178004466), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2019Disconnection; Disconnection
ON AUGUST 26TH, 2019, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT TIP OF THE S351-70 SUCKER DISSOLVES DURING PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. FOLLOW UP ATTEMPTS TO CLARIFY THE FAILURE WITH THE CUSTOMER WERE IN SUCCESSFUL AND THE CASE WAS EVALUATED AS NOT REPORTABLE. ON NOVEMBER 25TH, 2019, DURING VISUAL INSPECTION OF THE RETURNED S351-70 SUCKER, IT WAS FOUND THAT THE TIP HAS DETACHED FROM THE REST OF THE SUCKER. BASED ON THIS EVIDENCE THE CASE HAS BEEN EVALUATED AS REPORTABLE AND A 30DAYS REPORT IS TO BE SUBMITTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9503498 ↗
Other SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS devices
- DLP® 10050Medtronic, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall6 reports
- DLP® 10052Medtronic, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 10053Medtronic, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall2 reports
- DLP® 10060Medtronic, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS1 recall0 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS9 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS6 reports
- DLP® 10051Medtronic, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
- Suction tip SU-xxxxxLivanova USA, Inc. · SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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