Gelsoft Plus™ 631407PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05037881115511), received between Feb 7, 2019 and Jun 27, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K162803, K955230); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING AN AXILLO-FEMORAL BYPASS, THE BIFURICATED GRAFT LOT 2003294573 WAS USED. THE SURGEON NOTED THAT THERE WAS A PREEXISTINGHOLE IN THE BIFURICATED GRAFT WHICH WAS DISCOVERED DURING SURGERY. THE PATIENT EXPERIENCED BLOOD LOSS WHEN THE GRAFT WAS IN SITU, AT WHICH POINT THE HOLE WAS FOUND TO BE IN THE BIFURICATE GRAFT. THE GRAFT REMAINED IMPLANTED AND THE HOLE REPAIRED WITH A PATCH OF UNUSED GRAFT MATERIAL. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NUMBER 9612515-2024-00044 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19622512 ↗
• InjuryJun 18, 2024Obstruction of Flow; Obstruction of Flow

  CLINICAL TRIAL: (B)(4) , SITE NO. (B)(4), PATIENT NO.: (B)(6) , IMPLANT DATE: ON (B)(6) 2019 EVENT DATE: 21 APR 24 EVENT: OCCLUSION. RELEVANT MEDICAL HISTORY OF INDICATION FOR SURGERY WAS AORTO-FEMORAL OCCLUSIVE DISEASE (SUBTYPE: ULCERATION). OCCLUSION OF THE ILIACOFEMORAL AXIS AND LEFT BRANCH OF THE AORTOBIFEMORAL BYPASS WITH NON-VIABLE ACUTE LIMB ISCHEMIA OF THE LEFT LEG. ACTION TAKEN BY THE CLINICIANS: REINTERVENTION OF EMBOLECTOMY ILIACOFEMORAL AORTA GRAFT LEFT AND PERCUTANEOUS ANGIOPLASTY + STENTING ON (B)(6) 2024. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 AND DISCHARGED ON (B)(6) 2024. PATIENT OUTCOME: RECOVERED, RESOLVED WITHOUT SEQUELAE. REPORTED BY THE CLINICIANS AS POSSIBLY DEVICE FAILURE/ DEFICIENCY/ PROCEDURE AND PRE-EXISTING CONDITION.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 19555740 ↗
• InjuryAug 15, 2023Off-Label Use; Off-Label Use

  OCCLUSIVE DISEASE - AORTO-AXILLARY. PANTHER STUDY POST MARKET STUDY: 3/1/33 S/P ASCENDING AORTA TO ICA BYPASS, ASCENDING TO RIGHT AXILLARY ARTERY BYPASS. RIGHT COMMON FEMORAL VEIN ACCESS. ON (B)(6) 2022, PRESENTED TO CLINIC FOR DRAINAGE. SURGERY ON (B)(6) 2022, NECK EXPLORATION AND WASHOUT FOR TORTUOSITY AND ELONGATION OF GRAFT PUSHING AGAINST TISSUE. ON (B)(6), A TOTAL REDO OF SURGERY. THE GRAFT HAD ELONGATED AND WAS PUSHING AGAINST AND ERODING THE SKIN. INFECTION RELATED TO TORTUOSITY AND ELONGATION OF THE GRAFT RESULTING IN INFECTION AND REDO OF ENTIRE PROCEDURE. PI REPORTED DEFICIENCY TO BMS AT TIME THE INCIDENT OCCURRED. REINTERVENTION #1: A 3 CM LONG INCISION WAS MADE ALONG THE OLD INCISION AND IMMEDIATELY UPON OPENING THE SKIN, THE GRAFT WAS EXPOSED. THE AREA WAS DRAINED AND IRRIGATED WITH SALINE SOLUTION AS WELL AS BETADINE SOLUTION. IT APPEARED THAT THE GRAFT SEVERE TORTUOSITY WHICH WAS PUSHING AGAINST THE SUBCUTANEOUS TISSUE TOWARDS THE SKIN ERODING THROUGH THE PLATYSMA AND SUBCUTANEOUS TISSUE. THUS THE DECISION WAS MADE TO RESECT THE GRAFT TO FORESHORTEN. THREE CM OF THE GRAFT WAS EXCISED THE GRAFT WAS THEN REANASTOMOSED, SUTURED, IRRIGATED AND THE WOUND WAS CLOSED. REIN

  Patient problems: Failure of Implant

  MAUDE report 17547640 ↗
• MalfunctionJun 6, 2022Stretched; Stretched

  A GELSOFT PLUS BIFURCATE WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT UNDERWENT A PROCEDURE RELATING TO A WOUND INFECTION. DURING THE CTA IT WAS DETECTED THAT THE GRAFT APPEARED CLOSE TO THE SKIN. DURING THE INTERVENTION THE GRAFT WAS EXPLANTED AS IT APPEARED TO BE APPROX 3CM LONGER THAN WAS ANTICIPATED AND WAS CLOSE TO THE SKIN.

  Patient problems: Insufficient Information

  MAUDE report 14601344 ↗
• MalfunctionApr 7, 2021Material Integrity Problem; Material Integrity Problem

  DURING A PROCEDURE (AN EMERGENCY REPLACEMENT FOR A COMMON ILIAC ARTERY ANEURYSM) ON (B)(6) 2021, A CLINICIAN REPORTED BLOOD LEAKAGE AT THE BIFURCATION AREA OF THE GELSOFT PLUS BIFURCATE GRAFT. THE CLINICIAN ALSO INDICATED THAT THE STITCHING AT THE CRUTCH APPEARED LOOSE. THE LEAK WAS ARRESTED BY THE PLACEMENT OF TWO SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626903 ↗
• MalfunctionJan 27, 2021Material Puncture/Hole; Material Puncture/Hole

  CUSTOMER REPORTED DETECTING A SMALL HOLE IN THE GRAFT AFTER IT WAS SUTURED IN PLACE. HOLE WAS SUTURED USING PROLENE, THE GRAFT WAS DEEMED PATENT & THE PROCEDURE WAS COMPLETED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11234984 ↗
• MalfunctionAug 25, 2020Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  TERUMO (B)(4) WAS INFORMED BY (B)(6) ON 28-JUL-20 OF AN EVENT WHICH OCCURRED IN (B)(6) ON (B)(6) 2020 AS FOLLOWS: AFTER IMPLANTATION, THE OR TEAM NOTED AFTER DECLAMPING 2 HOLES AT THE BIFURCATION LEVEL. THE TEAM CLAMPED AND SEWED THE HOLES WITH A CONTINUOUS SUTURE BETWEEN AORTA AND PROSTHESIS. NO FURTHER TREATMENT WAS ADMINISTERED TO THE PATIENT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 10 MINUTES.

  Patient problems: No Information

  MAUDE report 10447040 ↗
• MalfunctionFeb 7, 2019Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # (B)(4) TO PROVIDE CLOSURE INFORMATION FOR THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8315755 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162803, K955230. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2021 · Jul 8, 2021 · Terminated
  The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Val