VASCBAND IPN914174Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10841156102043), received between Nov 13, 2020 and Aug 27, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Device Slipped; Device Slipped

  VASC BAND HEMOSTAT OPENED TO STERILE FIELD AND TESTED BY INFLATING WITH 20ML AIR. PLASTIC PIECE FELL OFF OF VASC BAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901644 ↗
• MalfunctionMar 18, 2025

  VASC BAND HEMOSTAT OPENED TO STERILE FIELD AND TESTED BY INFLATING WITH 20ML AIR. PLASTIC PIECE FELL OFF OF VASC BAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630788 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: THE VASCBAND AIR SELF-DEFLATING. HEMATOMA FORMED COMPRESSION HELD.

  Patient problems: Hematoma

  MAUDE report 18145977 ↗
• InjurySep 26, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: CUSTOMER STATES "VAC BAND LEAKING AIR. ISSUES WITH REBLEEDING, HEMATOMA AND VASCULAR SURGERY." ADDITIONAL INFORMATION: IT WAS CONFORMED THAT THE ISSUE WAS WITH 1 PATIENT AND 1 VASCBAND. THE PATIENT EXPERIENCED A HEMATOMA/BLEED IN THE RECOVERY UNIT POST PROCEDURE. VASCULAR SURGEON WAS CONSULTED BUT IT IS UNKNOWN IF THE PATIENT RETURNED TO SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17816882 ↗
• InjuryAug 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT: THIS COMPLAINT IS FOR THE FIRST VASCBAND THAT WAS APPLIED. ASSOCIATED TO. LHC PCI WAS PERFORMED ACCESS VIA THE RIGHT RADIAL ARTERY ON AN 80 Y/O FEMALE WITH FRAGILE SKIN INTEGRITY. A 6F SHEATH WAS USED IN THE PROCEDURE. PCI PROCEDURE DID NOT HAVE ANY KNOWN ISSUES/COMPLICATIONS. IT WAS REPORTED THAT THERE WAS A SKIN TEAR BESIDE THE ACCESS AREA PREVIOUS TO THE PCI PROCEDURE. POST PCI PROCEDURE, SHEATH PULLED BY MD. VASCBAND PLACED. THE PATIENT WAS TRANSFERRED FROM TABLE TO STRETCHER. IT WAS THEN REPORTED THAT THERE WAS A LARGE HEMATOMA PRESENT PROXIMAL TO THE VASCBAND. A SECOND VASCBAND WAS PLACED ABOVE THE FIRST VASCBAND. HEMATOMA CONTINUED TO GROW. BOTH BANDS WERE REMOVED, AND MANUAL PRESSURE WAS APPLIED. IT WAS REPORTED THAT THE PATIENT'S SKIN TORE AND CAUSED MODERATE BLEEDING. NO BLOOD TRANSFUSION WAS REQUIRED. VASCULAR SURGERY WAS CONSULTED AND DID A PRESSURE DRESSING. WOUND CONSULT WAS SCHEDULED FOR THE PATIENT. ADDITIONAL INFORMATION. THE CASE WAS A PCI. THE HEMATOMA WAS THE SIZE OF A TENNIS BALL. THERE WAS NO VISIBLE AIR LEAK. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17547696 ↗
• InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT: THIS COMPLAINT IS FOR THE SECOND VASCBAND THAT WAS APPLIED. ASSOCIATED TO 2134812-2023-00037. LHC PCI WAS PERFORMED ACCESS VIA THE RIGHT RADIAL ARTERY ON AN 80 Y/O FEMALE WITH FRAGILE SKIN INTEGRITY. A 6F SHEATH WAS USED IN THE PROCEDURE. PCI PROCEDURE DID NOT HAVE ANY KNOWN ISSUES/COMPLICATIONS. IT WAS REPORTED THAT THERE WAS A SKIN TEAR BESIDE THE ACCESS AREA PREVIOUS TO THE PCI PROCEDURE. POST PCI PROCEDURE, SHEATH PULLED BY MD. VASCBAND PLACED. THE PATIENT WAS TRANSFERRED FROM TABLE TO STRETCHER. IT WAS THEN REPORTED THAT THERE WAS A LARGE HEMATOMA PRESENT PROXIMAL TO THE VASCBAND (RELATED TO (B)(4)). A SECOND VASCBAND WAS PLACED ABOVE THE FIRST VASCBAND. (RELATED TO (B)(4)) HEMATOMA CONTINUED TO GROW. BOTH BANDS WERE REMOVED, AND MANUAL PRESSURE WAS APPLIED. IT WAS REPORTED THAT THE PATIENT'S SKIN TORE AND CAUSED MODERATE BLEEDING. NO BLOOD TRANSFUSION WAS REQUIRED. VASCULAR SURGERY WAS CONSULTED AND DID A PRESSURE DRESSING. WOUND CONSULT WAS SCHEDULED FOR THE PATIENT. ADDITIONAL INFORMATION. THE CASE WAS A PCI. THE HEMATOMA WAS THE SIZE OF A TENNIS BALL. THERE WAS NO VISIBLE AIR LEAK. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17541133 ↗
• MalfunctionAug 4, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: THE VASCBAND AIR SELF-DEFLATING. HEMATOMA WAS FORMED AND COMPRESSION WAS HELD. THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE". ADDITIONAL INFORMATION WAS REQUESTED AND NO INFORMATION WAS RECEIVED REGARDING MEDICAL INTERVENTION.

  Patient problems: Hematoma

  MAUDE report 17458148 ↗
• MalfunctionNov 13, 2020Inflation Problem; Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF HYPERTENSION AND NEW ONSET OF CHEST PRESSURE. HAVING A HEART CATH, THE VASC BAND WAS USED IN THE RIGHT, RADIAL ARTERY. BALLOON WOULD NOT GET FIRM AND THE PATIENT KEPT BLEEDING. WHEN THE JUNCTURE OF THE TUBING WAS MOVED, IT WAS DISCOVERED THAT THE INFLATABLE CUFF WAS KINKED AT THE CONNECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10835630 ↗