ARROW IPN032600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902097897), received between May 2, 2025 and May 28, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE PATIENT WAS FITTED WITH A HEIMLICH VALVE. ON (B)(6) 2024, WHILE THE PATIENT WAS HOSPITALIZED, HER HEIMLICH VALVE BECAME DETACHED. SHE THEN REATTACHED IT INCORRECTLY ON HER OWN (WITHOUT TELLING THE HOSPITAL STAFF ABOUT IT). DURING THIS INCIDENT, THE PATIENT SHOWED SIGNS OF TENSION PNEUMOTHORAX (DYSPNEA, DECREASED OXYGEN SATURATION). WHEN THE HOSPITAL STAFF NOTICED THIS, THEY CALLED THE DUTY DOCTOR, WHO THEN REFITTED THE HEMLICH VALVE CORRECTLY. THE PATIENT'S CONDITION SUBSEQUENTLY IMPROVED." ADDITIONAL INFORMATION RECEIVED STATES "SATURATION AFTER THE DISCONNECTION WAS 88%, AFTER THE INTERVENTION THE SATURATION INCREASED BACK TO 95%. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 22096648 ↗
• InjuryMay 2, 2025Obstruction of Flow; Connection Problem; Obstruction of Flow; Connection Problem

  IT WAS REPORTED " ON (B)(6) 2025, A PATIENT WITH A PNEUMOTHORAX HAD A DRAINAGE PORT WITH AN EXSUFFLATION (HEIMLICH) VALVE INSERTED. ON (B)(6) 2025, THE PATIENT'S VALVE BECAME DETACHED DURING HIS MORNING SHOWER, AND HE REATTACHED IT HIMSELF. A NURSE DETERMINED THAT THE VALVE HAD BEEN INCORRECTLY ATTACHED. IT WAS ORIENTED INCORRECTLY, THEREBY BLOCKING LIQUID DRAINAGE. THE PATIENT HAD DECREASED SATURATION BUT WAS OTHERWISE UNHARMED. THIS IS THE THIRD SIMILAR INCIDENT INVOLVING THE SAME DEVICE IN THE PAST 12 MONTHS." ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00368, 9680794-2025-00369, AND 9680794-2025-00370.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21950566 ↗
• MalfunctionMay 2, 2025Obstruction of Flow; Connection Problem; Obstruction of Flow; Connection Problem

  IT WAS REPORTED " ON (B)(6) 2025, A PATIENT WITH A PNEUMOTHORAX HAD A DRAINAGE PORT WITH AN EXSUFFLATION (HEIMLICH) VALVE INSERTED. ON (B)(6) 2025, THE PATIENT'S VALVE BECAME DETACHED DURING HIS MORNING SHOWER, AND HE REATTACHED IT HIMSELF. A NURSE DETERMINED THAT THE VALVE HAD BEEN INCORRECTLY ATTACHED. IT WAS ORIENTED INCORRECTLY, THEREBY BLOCKING LIQUID DRAINAGE. THE PATIENT HAD DECREASED SATURATION BUT WAS OTHERWISE UNHARMED. THIS IS THE THIRD SIMILAR INCIDENT INVOLVING THE SAME DEVICE IN THE PAST 12 MONTHS. " THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00368 AND 9680794-2025-00370.

  Patient problems: Insufficient Information; Low Oxygen Saturation

  MAUDE report 21950557 ↗
• MalfunctionMay 2, 2025Obstruction of Flow; Connection Problem; Obstruction of Flow; Connection Problem

  IT WAS REPORTED "ON (B)(6).2025, A PATIENT WITH A PNEUMOTHORAX HAD A DRAINAGE PORT WITH AN EXSUFFLATION (HEIMLICH) VALVE INSERTED. ON (B)(6).2025, THE PATIENT'S VALVE BECAME DETACHED DURING HIS MORNING SHOWER, AND HE REATTACHED IT HIMSELF. A NURSE DETERMINED THAT THE VALVE HAD BEEN INCORRECTLY ATTACHED. IT WAS ORIENTED INCORRECTLY, THEREBY BLOCKING LIQUID DRAINAGE. THE PATIENT HAD DECREASED SATURATION BUT WAS OTHERWISE UNHARMED. THIS IS THE THIRD SIMILAR INCIDENT INVOLVING THE SAME DEVICE IN THE PAST 12 MONTHS. " THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00368, 9680794-2025-00369, AND 9680794-2025-00370.

  Patient problems: Insufficient Information

  MAUDE report 21950403 ↗