Intergard IGK1407Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401000471), received between Oct 12, 2015 and Mar 30, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K964625); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Moisture or Humidity Problem

  IT WAS REPORTED TO INTERVASCULAR THAT THE CUSTOMER ALLEGED THAT HUMIDITY LEVELS WERE OVER 80% FOR MORE THAN 24 HOURS AND DID REACH 100%. THE DISTRIBUTOR, INTERMED HAD ONE OF REPS VISIT THE CUSTOMER SITE FOR AN ON-SITE INSPECTION OF THE PRODUCTS. SOME PRODUCTS HAD BUBBLING ON THE LABELLING. IT WAS DESCRIBED THAT ALL PRODUCTS FELT COLD AS IF LIKE THEY WERE DEFROSTED. IT WAS SUSPECTED THAT THE PRODUCTS WERE EXPOSED TO EXTREMELY HIGH LEVELS OF MOISTURE. THE IMPACTED PRODUCTS INCLUDE 12 INTERVASCULAR HEMAGARD AND INTERGARD GRAFTS. TWELVE SEPARATE COMPLAINTS WERE CREATED FOR EACH AFFECTED PRODUCTS. ACCORDINGLY, TWELVE INDIVIDUAL EMDR SUBMISSIONS WILL BE SUBMITTED. THIS EMDR IS PART OF A SERIES OF TWELVE EMDRS SUBMITTED FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714692 ↗
• MalfunctionNov 4, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO INTERVASCULAR THAT ONE OF THE BRANCHES OF THE PROSTHESIS WAS LEAKING BLOOD, AFTER WAITING FOR A WHILE, NO MORE LEAKS WERE DETECTED, AND IT CONTINUED TO BE USED ON THE PATIENT DURING THE SURGERY. NO IMPACT ON PATIENT WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20598645 ↗
• MalfunctionOct 17, 2024Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO INTERVASCULAR THAT DURING AN AORTO BIFEMORAL BYPASS PROCEDURE, THE GRAFT DOES NOT APPEAR TO BE TIGHT ALONG ITS ENTIRE LENGTH AND ¿OOZES¿ AFTER FITTING. THE CUSTOMER INDICATES THAT THE CONSEQUENCES CANNOT BE ASSESSED IN THE LONG TERM. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20471075 ↗
• MalfunctionDec 3, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  SEE MFG REPORT(S) 1640201-2021-00038. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923797 ↗
• MalfunctionDec 14, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPLAINT #(B)(4). THE FORWARDER HAD A BAD HANDLE OF THE BOX DURING THE TRANSPORT TO THE DISTRIBUTOR. THE PRODUCT BOX IS DAMAGED BUT THE PRODUCT IS OK ACCORDING TO THE COMPLAINANT.

  Patient problems: No Patient Involvement

  MAUDE report 11004292 ↗
• InjuryFeb 5, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  AFTER THE BIFURCATED GRAFT WAS PLACED IN THE PATIENT, BLOOD OOZED FROM ALL OVER THE GRAFT. THE AMOUNT OF BLOOD LEAKAGE IS UNKNOWN. THE SURGEON REPLACED IT WITH ANOTHER GRAFT WITH REFERENCE IGK1608 (I.E. ONE WITH A LARGER DIAMETER) AND NO BLOOD LEAKAGE OCCURRED WITH THIS SECOND GRAFT. THE SURGERY WAS PROLONGED FOR 15-20 MINUTES. THE GRAFT IS AVAILABLE FOR INVESTIGATION. A VIDEO OF THE BLEEDING IS AVAILABLE FOR INVESTIGATION. THE PATIENT'S CONDITION IS STABLE.

  Patient problems: Blood Loss

  MAUDE report 8304062 ↗
• InjuryOct 12, 2015Manufacturing, Packaging or Shipping Problem

  DURING AN INFRARENAL AORTIC OCCLUSION SURGERY PERFORMED ON (B)(6) 2015, THE GRAFT WAS REPORTED TO BLEED EXCESSIVELY, WHICH REQUIRED BLOOD TRANSFUSION. ANTIFIBRINOLYTIC MEDICATION WAS ADMINISTERED. THE EVENT HAS BEEN COMMUNICATED TO THE DESIGNATED COMPLAINT HANDLING UNIT ON (B)(6) 2015.

  Patient problems: Blood Loss

  MAUDE report 5144087 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964625. One submission often covers many models, so check the product and lot details in each record.

• Z-1439-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K9842
• Z-1427-2010 · Dec 9, 2009 · Terminated
  InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in th