FDA DeviceClass INotable

FDA Recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1

Date: 2026-06-03
Brand: Bolton Medical Inc.
Category: Medical Device
FDA Class: Class I

Description

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

Hazard

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

View original recall →
Share:

Related Recalls

2026-07-15 · FDA_DEVICE
FDA Recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr
Elekta, Inc.
2026-07-15 · FDA_DEVICE
FDA Recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Mo
Medline Industries, LP
2026-07-15 · FDA_DEVICE
FDA Recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1.
Fresenius Medical Care Holdings, Inc.
2026-07-15 · FDA_DEVICE
FDA Recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences Corp. (NeuroSciences)