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Open, Classified

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

FDA Recall Z-0998-2023 · Posted 2023-01-19

Recalling FirmBolton Medical Inc.
Recall StatusOpen, Classified
Product CodeMIH
Date Initiated2022-12-20
Product Quantity640 units

Reason for Recall

The product may be shorter than packaging indicates

Firm Action

On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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