Intergard IGK1809Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00384401000495), received between Dec 20, 2018 and Sep 3, 2026 — classified as 6 injuries, 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjurySep 3, 2026Leak/Splash

  It was reported to Intervascular that during the surgical procedure, porosity of the graft was identified at several locations, resulting in bleeding from multiple positions. The bleeding stopped spontaneously and the patient is currently in good condition. The patient is well and stable.Complaint (b)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50591580 ↗
• 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 24714259 ↗
• InjuryJul 24, 2023Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR FROM THE HOSPITAL THAT WHEN THE PROSTHESIS WAS PUT IN PLACE, THE CUSTOMER NOTICED IT WAS POROUS AND LOCALIZED BLEEDING WAS OBSERVED. STICHES WERE PERFORMED TO STOP THE BLEEDING, THEREFORE THE SURGERY WAS DELAYED. THE PRODUCT REMAINED IMPLANTED. TO DATE, A PATIENT INJURY IS UNKNOWN. THE SURGEON IS EXPERIENCED WITH INTERGARD PRODUCTS. PLEASE NOTE THAT ANOTHER CASE COMPLAINT MANUFACTURER REFERENCE # (B)(6), WITH THE SAME INITIAL DESCRIPTION AND INVOLVING A DIFFERENT PATIENT AND A DIFFERENT PRODUCT REFERENCE, WAS REPORTED BY THE SAME CUSTOMER AND ON THE SAME DATE. A SECOND MDR WILL BE SUBMITTED IN PARALLEL FOR THE ABOVE REFERENCED CASE. COMPLAINT MANUFACTURER REFERENCE # (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17379724 ↗
• InjuryJul 19, 2023Nonstandard Device; Product Quality Problem; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR FROM THE HOSPITAL THAT WHEN THE PROSTHESIS WAS PUT IN PLACE, THE CUSTOMER NOTICED IT WAS POROUS AND LOCALIZED BLEEDING WAS OBSERVED. STICHES WERE PERFORMED TO STOP THE BLEEDING, THEREFORE THE SURGERY WAS DELAYED. THE PRODUCT REMAINED IMPLANTED. TO DATE, A PATIENT INJURY IS UNKNOWN. THE SURGEON IS EXPERIENCED WITH INTERGARD PRODUCTS. PLEASE NOTE THAT ANOTHER CASE (COMPLAINT MANUFACTURER REFERENCE#: (B)(4) WITH THE SAME INITIAL DESCRIPTION AND INVOLVING A DIFFERENT PATIENT AND A DIFFERENT PRODUCT REFERENCE, WAS REPORTED BY THE SAME CUSTOMER AND ON THE SAME DATE. A SECOND MDR WILL BE SUBMITTED IN PARALLEL FOR THE ABOVE REFERENCED CASE. COMPLAINT MANUFACTURER REFERENCE#: (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17350018 ↗
• InjuryOct 18, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  SEE INITIAL MFR REPORT # 1640201-2019-00078. COMPLAINT # (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9211455 ↗
• InjuryOct 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  COMPLAINT REFERENCE (B)(4).

  Patient problems: Blood Loss

  MAUDE report 9166156 ↗
• InjuryDec 20, 2018Material Puncture/Hole; Material Puncture/Hole

  THE BIFURCATED GRAFT WAS INITIALLY IMPLANTED INTO THE PATIENT ON (B)(6) 2007. BLOOD LEAKED FROM A HOLE ON THE LATERAL SIDE OF THE LEFT LEG OF THE GRAFT AND A PSEUDOANEURYSM WAS FORMED OVER THE YEARS. THE RE-OPERATION WAS PERFORMED ON (B)(6) 2018 TO REPLACE THE GRAFT WITH A NEW ONE. ACCORDING TO THE SURGEON, THE PSEUDOANEURYSM HAD BEEN FORMED OUT OF THE HOLE OF THE NEEDLE PUNCTURE FOR DE-AIRING DURING THE PREVIOUS SURGERY IN 2007. THE EXPLANTED GRAFT FRAGMENTS ARE AVAILABLE FOR INVESTIGATION. THE PATIENT IS STABLE.

  Patient problems: Pseudoaneurysm

  MAUDE report 8184301 ↗

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-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
• 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