Synergy Grafts

Recalling firm
Getinge Australia Pty Ltd (NZ)
Product
Synergy Grafts. [Device]. Model: Intergard Synergy Knitted. Affected: Lot: 1690504264 - The affected products listed are manufactured from April to July 2026
Reason
A defect was identified within the body of Intergard Knitted straight vascular grafts from specific textile batches. The defect in question is small loops of yarn within the lumen of the grafts, which are not visible from the external side of the grafts., The presence of one or more yarn loops within the lumen of an Intergard Standard or Intergard Synergy Knitted vascular graft is associated with a low likelihood of causing clinically significant adverse consequences. The defect is not expected to be readily detectable by the surgeon or perioperative staff before or during implantation;...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-08-31
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/610a8c3a-2df2-477c-a1c6-e9de499babd0