ARROW IPN039786Recalls & reported problems
Teleflex Incorporated · RediGuard(R) IAB · Class 2
- 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 10801902145694), received between Oct 21, 2022 and Oct 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Gas/Air Leak1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2022Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT "AFTER INSERTION, THE IAB WAS CONNECTED TO THE PUMP AND THE PUMP GAVE A 'HELIUM LOSS' ALARM. [THE CLINICIAN] TRIED A SECOND PUMP, BUT THE SAME ALARM WAS REPORTED". ADDITIONAL INFORMATION STATES "THE IAB WAS REMOVED AND NO SECOND ATTEMPT [TO INSERT A SECONDARY CATHETER] WAS PERFORMED". THE PATIENT WAS "TREATED WITH DIFFERENT THERAPY, OTHER THAN IAB". THE CUSTOMER STATED THAT THE "PATIENT WAS CRITICALLY ILL BEFORE THE INCIDENT" AND THAT THE CURRENT CONDITION OF THE PATIENT IS "UNKNOWN". FURTHER INFORMATION STATES THAT THERE WERE NO ISSUES WITH EITHER PUMP.
Patient problems: Insufficient Information
MAUDE report 15654699 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.