Maquet Cardiovascular, Llc: Electrosurgical, Cutting & Coagulation & Accessories
Recall Summary Maquet Cardiovascular is recalling Vasoview Hemopro 2 Endoscopic Vessel Harvesting System devices from Lot 3000547797 because they received an improper sterilization dose during processing at a STERIS facility in March-April 2026. These single-use surgical devices are used in blood vessel harvesting procedures. The affected devices were distributed nationwide across multiple states.
- Recalling firm
- Maquet Cardiovascular, LLC
- Product
- The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
- Reason
- Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-02
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6b2f299a-1eb9-4223-a712-ec19ff1ccaf7